Trial Outcomes & Findings for Care After Pregnancy Study (CAPS): Engaging Women in Postpartum Care (NCT NCT04257552)
NCT ID: NCT04257552
Last Updated: 2022-10-21
Results Overview
Effective contraception (non-barrier method)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
128 participants
Primary outcome timeframe
3 months after delivery
Results posted on
2022-10-21
Participant Flow
Participant milestones
| Measure |
Attention Control Group
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
43
|
|
Overall Study
COMPLETED
|
42
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Care After Pregnancy Study (CAPS): Engaging Women in Postpartum Care
Baseline characteristics by cohort
| Measure |
Attention Control Group
n=42 Participants
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
n=43 Participants
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
n=43 Participants
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
27 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
27 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
27 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
128 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 months after deliveryEffective contraception (non-barrier method)
Outcome measures
| Measure |
Attention Control Group
n=42 Participants
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
n=43 Participants
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
n=43 Participants
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
|---|---|---|---|
|
Number of Participants Using a Non-barrier Method of Contraception
|
24 Participants
|
29 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 6 months after deliveryEffective contraception (non-barrier method)
Outcome measures
| Measure |
Attention Control Group
n=42 Participants
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
n=43 Participants
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
n=43 Participants
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
|---|---|---|---|
|
Number of Participants Using a Non-barrier Method of Contraception
|
19 Participants
|
26 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after delieryAttendance at postpartum visit (yes/no)
Outcome measures
| Measure |
Attention Control Group
n=42 Participants
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
n=43 Participants
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
n=43 Participants
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
|---|---|---|---|
|
Adherence of Postpartum Visit
|
25 Participants
|
25 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 1 week after deliveryRates of breast feeding
Outcome measures
| Measure |
Attention Control Group
n=32 Participants
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
n=34 Participants
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
n=35 Participants
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
|---|---|---|---|
|
The Number of Participants Who Given Their Infant Breast Milk
Breast Milk Only
|
4 Participants
|
11 Participants
|
6 Participants
|
|
The Number of Participants Who Given Their Infant Breast Milk
Formula Only
|
13 Participants
|
8 Participants
|
12 Participants
|
|
The Number of Participants Who Given Their Infant Breast Milk
Both Breast Milk and Formula
|
15 Participants
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 1 month after deliveryRates of breast feeding
Outcome measures
| Measure |
Attention Control Group
n=34 Participants
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
n=29 Participants
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
n=31 Participants
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
|---|---|---|---|
|
The Number of Participants Who Given Their Infant Breast Milk
Breast Milk Only
|
4 Participants
|
7 Participants
|
6 Participants
|
|
The Number of Participants Who Given Their Infant Breast Milk
Formula Only
|
18 Participants
|
14 Participants
|
17 Participants
|
|
The Number of Participants Who Given Their Infant Breast Milk
Breast Milk and Formula
|
12 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 3 months after deliveryRates of breast feeding
Outcome measures
| Measure |
Attention Control Group
n=23 Participants
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
n=25 Participants
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
n=26 Participants
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
|---|---|---|---|
|
The Number of Participants Who Given Their Infant Breast Milk
Breast Milk Only
|
3 Participants
|
5 Participants
|
6 Participants
|
|
The Number of Participants Who Given Their Infant Breast Milk
Formula Only
|
20 Participants
|
17 Participants
|
12 Participants
|
|
The Number of Participants Who Given Their Infant Breast Milk
Breast Milk and Formula
|
0 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 months after deliveryRates of breast feeding
Outcome measures
| Measure |
Attention Control Group
n=25 Participants
If randomized to the attention control arm participants will receive discharge instruction from the postpartum nurses per usual care. Study investigators will ask them to provide us with an SMS number. This will enable collection of self-reported breast feeding duration as well as texts on general infant care. The infant care texts are educational in nature and no data will be collected. Participants will receive a total of two texts on general infant care in the first month postpartum. This increased attention to the control arm mirrors the attention received by the Healthy Beyond Pregnancy arms and seeks to isolate the effect of the intervention from a general increased level of contact with providers.
Attention Control: Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
|
Pre-Scheduled Postpartum Visit:
n=20 Participants
If randomized the usual care with pre-scheduled visit arm, participants will schedule their postpartum visit with the study coordinator and receive discharge information per usual care.
Pre-Scheduled Postpartum Visit: Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
|
Healthy Beyond Pregnancy
n=20 Participants
Healthy Beyond Pregnancy is a web platform with an electronic survey that assesses a participant's self-identified postpartum concerns. Participants are then presented with 3 educational videos that reflect their self-identified needs from the survey. The Healthy Beyond Pregnancy generates an individualized passport for postpartum care. This passport for care lists the women's self-identified postpartum needs as well as issues that should be prioritized based on her health history. The individualized passport for postpartum care will be printed out and given to participants. After the participant schedules her postpartum visit, she will receive a printout that includes the date and time of her appointment, a copy of the commitment statement.
Healthy Beyond Pregnancy: Web-based application grounded in tenants of behavioral economics.
|
|---|---|---|---|
|
The Number of Participants Who Given Their Infant Breast Milk
Formula Only
|
18 Participants
|
16 Participants
|
13 Participants
|
|
The Number of Participants Who Given Their Infant Breast Milk
Breast Milk Only
|
5 Participants
|
3 Participants
|
3 Participants
|
|
The Number of Participants Who Given Their Infant Breast Milk
Breast and Formula
|
2 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
Attention Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-Scheduled Postpartum Visit:
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Beyond Pregnancy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Katherine Himes
University of Pittsburgh, Magee Womens Research Institute
Phone: (412) 641-1805
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place