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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

280 participants

Primary outcome timeframe

2 weeks postpartum

Results posted on

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

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

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

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 postpartum

Population: 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

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 postpartum

Population: 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

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

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 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) 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

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 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) 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

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 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) 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

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 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) 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

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 postpartum

Population: 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 weeks

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) or did not complete a survey at this timepoint.

Categorical outcome indicating proportional range of breast milk feeds since infant was born

Outcome measures

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 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) 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

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 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) 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

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 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) 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

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 postpartrum

Population: 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

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 postpartum

Population: 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

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

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 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) 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

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 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) 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

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 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) 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

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 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) 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

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 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) 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

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 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) or did not complete a survey at this timepoint.

Recall of lactogenesis II in post-birth days

Outcome measures

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 postpartum

Population: 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

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 postpartum

Population: 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

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 postpartum

Population: 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

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 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) or did not complete a survey at this timepoint.

Endorsement of insufficient milk supply via investigator created item (dichotomous outcome)

Outcome measures

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 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) 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

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 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) 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

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 postpartum

Population: 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

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

Serious events: 71 serious events
Other events: 113 other events
Deaths: 0 deaths

Video-based Infant Care Education Control Group

Serious events: 66 serious events
Other events: 74 other events
Deaths: 0 deaths

Serious adverse events

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

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

Dr. Jill Demirci

University of Pittsburgh

Phone: 412-648-9236

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place