Trial Outcomes & Findings for PRenatal Video-Based Education and PostPARtum Effects (NCT NCT04258709)
NCT ID: NCT04258709
Last Updated: 2025-03-19
Results Overview
Whether participant is feeding 100% breast milk at 2 weeks postpartum
COMPLETED
NA
280 participants
2 weeks postpartum
2025-03-19
Participant Flow
Participants were enrolled between September 23, 2020 and October 23, 2023. Recruitment occurred via electronic health record scans of prenatal practices involved in the study for patients who met basic eligibility criteria, who then received study advertisements, health system portal messages, and/or approaches by study staff at a prenatal visit. Other recruitment strategies included social media ads, a university research registry, study flyers at clinical sites, and magazine advertisements.
Of 539 participants assessed for eligibility, 280 met eligibility criteria, agreed to participate, and were randomized to an interventionist group.
Participant milestones
| Measure |
Antenatal Milk Expression (AME) Intervention Group
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
Video-based Infant Care Education Control Group
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
140
|
|
Overall Study
COMPLETED
|
128
|
134
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
| Measure |
Antenatal Milk Expression (AME) Intervention Group
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
Video-based Infant Care Education Control Group
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Fetal demise
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Ethnicity assessed at baseline with n=279 participants' data available
Baseline characteristics by cohort
| Measure |
Antenatal Milk Expression (AME) Intervention Group
n=140 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
Video-based Infant Care Education Control Group
n=140 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 4.71 • n=140 Participants
|
31.12 years
STANDARD_DEVIATION 5.2 • n=140 Participants
|
30.57 years
STANDARD_DEVIATION 4.98 • n=280 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=140 Participants
|
140 Participants
n=140 Participants
|
280 Participants
n=280 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=140 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=280 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=139 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
5 Participants
n=140 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
9 Participants
n=279 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
133 Participants
n=139 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
134 Participants
n=140 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
267 Participants
n=279 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=139 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
1 Participants
n=140 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
3 Participants
n=279 Participants • Ethnicity assessed at baseline with n=279 participants' data available
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=139 Participants • Race assessed at baseline with n=279 participants' data available
|
0 Participants
n=140 Participants • Race assessed at baseline with n=279 participants' data available
|
1 Participants
n=279 Participants • Race assessed at baseline with n=279 participants' data available
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=139 Participants • Race assessed at baseline with n=279 participants' data available
|
9 Participants
n=140 Participants • Race assessed at baseline with n=279 participants' data available
|
15 Participants
n=279 Participants • Race assessed at baseline with n=279 participants' data available
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=139 Participants • Race assessed at baseline with n=279 participants' data available
|
0 Participants
n=140 Participants • Race assessed at baseline with n=279 participants' data available
|
0 Participants
n=279 Participants • Race assessed at baseline with n=279 participants' data available
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=139 Participants • Race assessed at baseline with n=279 participants' data available
|
18 Participants
n=140 Participants • Race assessed at baseline with n=279 participants' data available
|
28 Participants
n=279 Participants • Race assessed at baseline with n=279 participants' data available
|
|
Race (NIH/OMB)
White
|
111 Participants
n=139 Participants • Race assessed at baseline with n=279 participants' data available
|
106 Participants
n=140 Participants • Race assessed at baseline with n=279 participants' data available
|
217 Participants
n=279 Participants • Race assessed at baseline with n=279 participants' data available
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=139 Participants • Race assessed at baseline with n=279 participants' data available
|
5 Participants
n=140 Participants • Race assessed at baseline with n=279 participants' data available
|
12 Participants
n=279 Participants • Race assessed at baseline with n=279 participants' data available
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=139 Participants • Race assessed at baseline with n=279 participants' data available
|
2 Participants
n=140 Participants • Race assessed at baseline with n=279 participants' data available
|
6 Participants
n=279 Participants • Race assessed at baseline with n=279 participants' data available
|
|
Region of Enrollment
United States
|
140 Participants
n=140 Participants
|
140 Participants
n=140 Participants
|
280 Participants
n=280 Participants
|
|
Married
Married
|
105 Participants
n=139 Participants • Marital status assessed at baseline with n=279 participants' data available
|
106 Participants
n=140 Participants • Marital status assessed at baseline with n=279 participants' data available
|
211 Participants
n=279 Participants • Marital status assessed at baseline with n=279 participants' data available
|
|
Married
Living with a partner
|
21 Participants
n=139 Participants • Marital status assessed at baseline with n=279 participants' data available
|
20 Participants
n=140 Participants • Marital status assessed at baseline with n=279 participants' data available
|
41 Participants
n=279 Participants • Marital status assessed at baseline with n=279 participants' data available
|
|
Married
Single or separated
|
13 Participants
n=139 Participants • Marital status assessed at baseline with n=279 participants' data available
|
14 Participants
n=140 Participants • Marital status assessed at baseline with n=279 participants' data available
|
27 Participants
n=279 Participants • Marital status assessed at baseline with n=279 participants' data available
|
|
Education level
Associates degree
|
9 Participants
n=139 Participants • Education level assessed at baseline with n=279 participants' data available
|
5 Participants
n=140 Participants • Education level assessed at baseline with n=279 participants' data available
|
14 Participants
n=279 Participants • Education level assessed at baseline with n=279 participants' data available
|
|
Education level
Bachelor's degree
|
43 Participants
n=139 Participants • Education level assessed at baseline with n=279 participants' data available
|
52 Participants
n=140 Participants • Education level assessed at baseline with n=279 participants' data available
|
95 Participants
n=279 Participants • Education level assessed at baseline with n=279 participants' data available
|
|
Education level
Completed occupational or vocational program
|
6 Participants
n=139 Participants • Education level assessed at baseline with n=279 participants' data available
|
0 Participants
n=140 Participants • Education level assessed at baseline with n=279 participants' data available
|
6 Participants
n=279 Participants • Education level assessed at baseline with n=279 participants' data available
|
|
Education level
Graduated from high school/GED
|
9 Participants
n=139 Participants • Education level assessed at baseline with n=279 participants' data available
|
13 Participants
n=140 Participants • Education level assessed at baseline with n=279 participants' data available
|
22 Participants
n=279 Participants • Education level assessed at baseline with n=279 participants' data available
|
|
Education level
Master's or doctoral degree
|
55 Participants
n=139 Participants • Education level assessed at baseline with n=279 participants' data available
|
60 Participants
n=140 Participants • Education level assessed at baseline with n=279 participants' data available
|
115 Participants
n=279 Participants • Education level assessed at baseline with n=279 participants' data available
|
|
Education level
Some college, no degree
|
15 Participants
n=139 Participants • Education level assessed at baseline with n=279 participants' data available
|
9 Participants
n=140 Participants • Education level assessed at baseline with n=279 participants' data available
|
24 Participants
n=279 Participants • Education level assessed at baseline with n=279 participants' data available
|
|
Education level
Unknown
|
2 Participants
n=139 Participants • Education level assessed at baseline with n=279 participants' data available
|
1 Participants
n=140 Participants • Education level assessed at baseline with n=279 participants' data available
|
3 Participants
n=279 Participants • Education level assessed at baseline with n=279 participants' data available
|
|
Employed at enrollment
No
|
16 Participants
n=139 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
20 Participants
n=140 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
36 Participants
n=279 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
|
Employed at enrollment
Yes, but on leave until after baby's birth
|
6 Participants
n=139 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
4 Participants
n=140 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
10 Participants
n=279 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
|
Employed at enrollment
Yes, with reduced hours
|
9 Participants
n=139 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
14 Participants
n=140 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
23 Participants
n=279 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
|
Employed at enrollment
Yes, with the same number of hours as before pregnancy
|
106 Participants
n=139 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
101 Participants
n=140 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
207 Participants
n=279 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
|
Employed at enrollment
Unknown/unreported
|
2 Participants
n=139 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
1 Participants
n=140 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
3 Participants
n=279 Participants • Employment status at enrollment assessed at baseline with n=279 participants' data available
|
|
Special Supplemental Program for Women, Infants, and Children (WIC) recipient
Yes, current recipient
|
16 Participants
n=139 Participants • WIC status assessed at baseline with n=279 participants' data available
|
14 Participants
n=140 Participants • WIC status assessed at baseline with n=279 participants' data available
|
30 Participants
n=279 Participants • WIC status assessed at baseline with n=279 participants' data available
|
|
Special Supplemental Program for Women, Infants, and Children (WIC) recipient
No, not a current recipient
|
121 Participants
n=139 Participants • WIC status assessed at baseline with n=279 participants' data available
|
125 Participants
n=140 Participants • WIC status assessed at baseline with n=279 participants' data available
|
246 Participants
n=279 Participants • WIC status assessed at baseline with n=279 participants' data available
|
|
Special Supplemental Program for Women, Infants, and Children (WIC) recipient
Unreported/unknown
|
2 Participants
n=139 Participants • WIC status assessed at baseline with n=279 participants' data available
|
1 Participants
n=140 Participants • WIC status assessed at baseline with n=279 participants' data available
|
3 Participants
n=279 Participants • WIC status assessed at baseline with n=279 participants' data available
|
|
Infant Feeding Intentions Scale Score at enrollment
|
10.59 units on a scale
STANDARD_DEVIATION 2.07 • n=137 Participants • Scale administered at baseline with n=276 participants' data available
|
10.40 units on a scale
STANDARD_DEVIATION 2.02 • n=139 Participants • Scale administered at baseline with n=276 participants' data available
|
10.49 units on a scale
STANDARD_DEVIATION 2.04 • n=276 Participants • Scale administered at baseline with n=276 participants' data available
|
|
Breastfeeding Self-Efficacy Scale (Short Form) Score Baseline
|
45.57 units on a scale
STANDARD_DEVIATION 8.04 • n=137 Participants • Scale administered at baseline with n=276 participants' data available
|
46.16 units on a scale
STANDARD_DEVIATION 8.43 • n=139 Participants • Scale administered at baseline with n=276 participants' data available
|
45.87 units on a scale
STANDARD_DEVIATION 8.23 • n=276 Participants • Scale administered at baseline with n=276 participants' data available
|
|
Iowa Infant Feeding Attitude Scale
|
44.42 units on a scale
STANDARD_DEVIATION 4.26 • n=137 Participants • Scale administered at baseline with n=276 participants' data available
|
44.19 units on a scale
STANDARD_DEVIATION 4.26 • n=139 Participants • Scale administered at baseline with n=276 participants' data available
|
44.30 units on a scale
STANDARD_DEVIATION 4.25 • n=276 Participants • Scale administered at baseline with n=276 participants' data available
|
|
Pre-pregnancy BMI
BMI 25.0-29.99
|
77 Participants
n=139 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
76 Participants
n=140 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
153 Participants
n=279 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
|
Pre-pregnancy BMI
BMI ≥ 30.0
|
62 Participants
n=139 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
64 Participants
n=140 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
126 Participants
n=279 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
|
Pre-pregnancy BMI (Continuous)
|
31.1 lbs/in^2
STANDARD_DEVIATION 5.69 • n=139 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
30.8 lbs/in^2
STANDARD_DEVIATION 5.87 • n=140 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
31.0 lbs/in^2
STANDARD_DEVIATION 5.77 • n=279 Participants • BMI at enrollment assessed at baseline with n=279 participants' data available
|
PRIMARY outcome
Timeframe: 2 weeks postpartumPopulation: Only includes participants with breastfeeding data available at 2 weeks postpartum (i.e., participants who completed breastfeeding survey item(s) at 2 weeks); note that some participants do not have 2 week breastfeeding data or 2 week survey data, but went on to complete the study by completing subsequent study timepoints
Whether participant is feeding 100% breast milk at 2 weeks postpartum
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=137 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=131 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Breastfeeding Exclusivity
|
84 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: 2 weeks postpartumPopulation: Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experiences.
Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=126 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=121 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Breastfeeding Self-efficacy
|
47.7 score on a scale
Standard Deviation 11.9
|
48.8 score on a scale
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: Postpartum hospitalization (0-4 days postpartum)Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff).
This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=137 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=138 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization
Not exclusively breastfeeding
|
61 Participants
|
59 Participants
|
|
Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization
Exclusively breastfeeding
|
76 Participants
|
79 Participants
|
SECONDARY outcome
Timeframe: 2 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
This variable derived from participant self-report survey emailed at 2 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=127 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=121 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum
Exclusively breastfeeding
|
46 Participants
|
45 Participants
|
|
Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum
Not exclusively breastfeeding
|
81 Participants
|
76 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
This variable derived from participant self-report survey emailed at 6 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=122 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=123 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum
Exclusively breastfeeding
|
73 Participants
|
64 Participants
|
|
Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum
Not exclusively breastfeeding
|
49 Participants
|
59 Participants
|
SECONDARY outcome
Timeframe: 12 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
This variable derived from participant self-report survey emailed at 12 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=111 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=104 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum
Exclusively breastfeeding
|
69 Participants
|
67 Participants
|
|
Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum
Not exclusively breastfeeding
|
42 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
This variable derived from participant self-report survey emailed at 6 months postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only).
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=101 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=94 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Exclusively Breastfeeding at 6 Months Postpartum
Exclusively breastfeeding
|
2 Participants
|
0 Participants
|
|
Number of Participants Exclusively Breastfeeding at 6 Months Postpartum
Not exclusively breastfeeding
|
99 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: 0-4 days postpartumPopulation: Data not collected from the EHR for the study due to reliability concerns
Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
Categorical outcome indicating proportional range of breast milk feeds since infant was born
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=127 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=121 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Breastfeeding Exclusivity (Categorical)
75-99% breast milk
|
56 Participants
|
45 Participants
|
|
Breastfeeding Exclusivity (Categorical)
100% breast milk
|
46 Participants
|
45 Participants
|
|
Breastfeeding Exclusivity (Categorical)
0% breast milk
|
0 Participants
|
0 Participants
|
|
Breastfeeding Exclusivity (Categorical)
1-74% breast milk
|
25 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Categorical outcome indicating proportional range of breast milk feeds in past week
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=122 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=123 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Breastfeeding Exclusivity (Categorical)
0% breast milk
|
15 Participants
|
15 Participants
|
|
Breastfeeding Exclusivity (Categorical)
1-75% breast milk
|
20 Participants
|
28 Participants
|
|
Breastfeeding Exclusivity (Categorical)
75-99% breast milk
|
14 Participants
|
16 Participants
|
|
Breastfeeding Exclusivity (Categorical)
100% breast milk
|
73 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 12 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Categorical outcome indicating proportional range of breast milk feeds in past week
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=111 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=104 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Breastfeeding Exclusivity (Categorical)
0% breast milk
|
8 Participants
|
8 Participants
|
|
Breastfeeding Exclusivity (Categorical)
1-74% breast milk
|
16 Participants
|
18 Participants
|
|
Breastfeeding Exclusivity (Categorical)
75-99% breast milk
|
17 Participants
|
10 Participants
|
|
Breastfeeding Exclusivity (Categorical)
100% breast milk
|
70 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Categorical outcome indicating proportional range of breast milk feeds in past week
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=101 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=94 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Breastfeeding Exclusivity (Categorical)
0% breast milk
|
11 Participants
|
13 Participants
|
|
Breastfeeding Exclusivity (Categorical)
1-74% breast milk
|
28 Participants
|
23 Participants
|
|
Breastfeeding Exclusivity (Categorical)
75-99% breast milk
|
40 Participants
|
38 Participants
|
|
Breastfeeding Exclusivity (Categorical)
100% breast milk.
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartrumPopulation: Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=122 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=123 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Breastfeeding Self-efficacy
|
48.8 score on a scale
Standard Deviation 13.1
|
49.7 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: 12 weeks postpartumPopulation: Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=111 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=104 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Breastfeeding Self-efficacy
|
49.7 score on a scale
Standard Deviation 14.3
|
52.6 score on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: Postpartum hospitalization (0-4 days postpartum)Population: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff).
This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=138 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=138 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)
No
|
2 Participants
|
0 Participants
|
|
Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum)
Yes
|
136 Participants
|
138 Participants
|
SECONDARY outcome
Timeframe: 2 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=137 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=131 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Breastfeeding at 2 Weeks Postpartum
Yes
|
127 Participants
|
121 Participants
|
|
Number of Participants Breastfeeding at 2 Weeks Postpartum
No
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=122 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=123 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Breastfeeding at 6 Weeks Postpartum
Yes
|
107 Participants
|
108 Participants
|
|
Number of Participants Breastfeeding at 6 Weeks Postpartum
No
|
15 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=111 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=104 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Breastfeeding at 12 Weeks Postpartum
Yes
|
103 Participants
|
96 Participants
|
|
Number of Participants Breastfeeding at 12 Weeks Postpartum
No
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 months postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=101 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=94 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Breastfeeding at 6 Months Postpartum
Yes
|
90 Participants
|
81 Participants
|
|
Number of Participants Breastfeeding at 6 Months Postpartum
No
|
11 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 months postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant.
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=91 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=83 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Breastfeeding at 12 Months Postpartum
Yes
|
51 Participants
|
50 Participants
|
|
Number of Participants Breastfeeding at 12 Months Postpartum
No
|
40 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 2 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
Recall of lactogenesis II in post-birth days
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=133 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=128 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Onset of Lactogenesis II
1 day or less
|
5 Participants
|
5 Participants
|
|
Onset of Lactogenesis II
2 days
|
15 Participants
|
16 Participants
|
|
Onset of Lactogenesis II
3 days
|
38 Participants
|
40 Participants
|
|
Onset of Lactogenesis II
4 days
|
40 Participants
|
32 Participants
|
|
Onset of Lactogenesis II
More than 4 days
|
31 Participants
|
33 Participants
|
|
Onset of Lactogenesis II
Never
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 weeks postpartumPopulation: Please note that this indicates the number of participants who completed the H\&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
Score on PIBBS subscale of H \& H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=127 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=121 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Perceived Milk Supply (Continuous)
|
27.7 score on a scale
Standard Deviation 6.69
|
26.5 score on a scale
Standard Deviation 7.92
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Please note that this indicates the number of participants who completed the H\&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
Score on PIBBS subscale of H \& H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=107 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=108 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Perceived Milk Supply (Continuous)
|
28.6 score on a scale
Standard Deviation 6.89
|
26.7 score on a scale
Standard Deviation 8.11
|
SECONDARY outcome
Timeframe: 12 weeks postpartumPopulation: Please note that this indicates the number of participants who completed the H\&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience.
Score on PIBBS subscale of H \& H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=103 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=96 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Perceived Milk Supply (Continuous)
|
29.6 score on a scale
Standard Deviation 6.67
|
26.7 score on a scale
Standard Deviation 8.11
|
SECONDARY outcome
Timeframe: 2 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint.
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=127 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=121 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Perceived Milk Supply (Dichotomous)
Perceived as insufficient
|
28 Participants
|
32 Participants
|
|
Perceived Milk Supply (Dichotomous)
Perceived as sufficient
|
99 Participants
|
89 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=107 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=108 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Perceived Milk Supply (Dichotomous)
Perceived as insufficient
|
26 Participants
|
31 Participants
|
|
Perceived Milk Supply (Dichotomous)
Perceived as sufficient
|
81 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: 12 weeks postpartumPopulation: Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey).
Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=103 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=96 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Perceived Milk Supply (Dichotomous)
Perceived as insufficient
|
22 Participants
|
22 Participants
|
|
Perceived Milk Supply (Dichotomous)
Perceived as sufficient
|
81 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: 6 weeks postpartumPopulation: Please note that this indicates the number of participants who were invited, agreed to participate, and completed a qualitative interview at 6 weeks postpartum.
A subset of participants took place in a qualitative assessment via semi-structured interview. Numbers below represent the number of participants who endorsed each of the following categories during their interview: 1) discussing the impact of the study on their pregnancy/postpartum experience, 2) integration of AME into their daily life, and 3) utilization of antenatal milk during the postpartum period
Outcome measures
| Measure |
Video-based Infant Care Education Control Group
n=16 Participants
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
Antenatal Milk Expression (AME) Intervention Group
n=31 Participants
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
|---|---|---|
|
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period
Impact of/motivation for AME
|
15 Participants
|
11 Participants
|
|
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period
Integration of AME into daily life
|
0 Participants
|
26 Participants
|
|
Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period
Utilization of milk collected antenatally
|
0 Participants
|
11 Participants
|
Adverse Events
Antenatal Milk Expression (AME) Intervention Group
Video-based Infant Care Education Control Group
Serious adverse events
| Measure |
Antenatal Milk Expression (AME) Intervention Group
n=139 participants at risk
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
Video-based Infant Care Education Control Group
n=139 participants at risk
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Polyhydramnios
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
1.4%
2/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
2.2%
3/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
NICU admission during postpartum hospitalization
|
9.4%
13/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
9.4%
13/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperbilirubinemia requiring phototherapy
|
5.8%
8/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
3.6%
5/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Reduced fetal movement during/after AME in past week
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Rupture of membranes during AME
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
19.4%
27/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
10.1%
14/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
5.8%
8/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
9.4%
13/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal distress as indication for delivery via caesarean section
|
4.3%
6/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
6.5%
9/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal demise
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Iron transfusion required during postpartum hospitalization
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Partial placental abruption
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
1.4%
2/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum hemorrhage
|
10.8%
15/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
7.9%
11/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Infant participant requiring resuscitation beyond SDS after delivery
|
2.2%
3/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
5.0%
7/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Infant with hyperbilirubinemia requiring monitoring only
|
10.1%
14/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
6.5%
9/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Infant with hypoglycemia
|
5.8%
8/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
4.3%
6/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Infant with clavicle fracture
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Infant with NAS and prolonged hospitalization
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Infant with hip dysplasia
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
In-patient hospitalization (unrelated to AME)
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
IUGR
|
1.4%
2/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum pre-E with SF
|
0.72%
1/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
0.00%
0/139 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
Other adverse events
| Measure |
Antenatal Milk Expression (AME) Intervention Group
n=139 participants at risk
Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk.
AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
|
Video-based Infant Care Education Control Group
n=139 participants at risk
Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.).
Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Oversupply at 2 weeks postpartum
|
28.3%
39/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
15.2%
21/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Delivery prior to 39 weeks
|
28.3%
39/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
22.5%
31/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Lactogenesis II onset < 2 days or > 4 days postpartum or no onset
|
28.3%
39/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
29.7%
41/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported emotional discomfort or anxiety with AME while on AME interventionist call
|
5.8%
8/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported hand fatigue/pain/discomfort with AME while on AME interventionist call
|
4.3%
6/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported breast/nipple discomfort associated with AME while on AME interventionist call
|
5.1%
7/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported breast or nipple pain or soreness via daily text diaries
|
23.2%
32/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported hand fatigue/hand cramping via daily text message diaries
|
18.1%
25/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported anxiety/uneasiness/embarrassment via daily text message diaries
|
11.6%
16/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported cramping via daily text message diary
|
1.4%
2/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported pelvic pain during daily text message diaries
|
0.72%
1/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported lightheadedness/nausea during expression via daily text message diary
|
0.72%
1/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
|
Pregnancy, puerperium and perinatal conditions
Participant reported no/little milk output via daily text message diaries
|
2.9%
4/138 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
—
0/0 • From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place