Trial Outcomes & Findings for A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes (NCT NCT06353256)
NCT ID: NCT06353256
Last Updated: 2026-08-05
Results Overview
Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10). Participant satisfaction with postpartum support received as part of the study, measured on a 1 to 10 scale where 1 = lowest satisfaction and 10 = highest satisfaction. Higher scores represent greater satisfaction (a better outcome).
COMPLETED
NA
61 participants
Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.
2026-08-05
Participant Flow
Participants were recruited during their delivery-associated hospitalization at a single tertiary care institution in Alabama. Eligible individuals were approached after experiencing an adverse pregnancy outcome, identified as Black or African American, spoke English, and delivered at ≥14 weeks gestation. Recruitment occurred from September 2024 to June 2025. Of 95 individuals assessed for eligibility, 61 (64%) consented and were randomized.
There were no significant events between enrollment and randomization. Participants were consented and randomized during their delivery-associated hospitalization. All 61 enrolled participants were randomized ; no participants were lost or withdrawn between enrollment and assignment.
Participant milestones
| Measure |
Usual Care and Community Health Worker Intervention
Participants received usual care (validated blood pressure cuff, BP monitoring education, CVD-prevention coaching, and an educational handout on weight management, smoking cessation, nutrition/physical activity, and breastfeeding) plus support from a community health worker (CHW) for 12 weeks postpartum. CHW support included coaching on home BP monitoring and medication adherence; connections to WIC and food/diaper banks; education on APO risks, breastfeeding, and infant care; collaborative exercise, nutrition, and smoking cessation plans based on AHA Life's Essential 8; navigation support for postpartum appointments; and linkage to a primary care provider. CHWs contacted participants approximately twice weekly for weeks 1-4 and once weekly for weeks 5-12, in person or by telephone.
|
Usual Care
Participants received usual care including a validated blood pressure cuff, BP monitoring education, CVD-prevention coaching, and an educational handout on weight management, smoking cessation, nutrition/physical activity counseling, and breastfeeding coaching.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Usual Care and Community Health Worker Intervention
Participants received usual care (validated blood pressure cuff, BP monitoring education, CVD-prevention coaching, and an educational handout on weight management, smoking cessation, nutrition/physical activity, and breastfeeding) plus support from a community health worker (CHW) for 12 weeks postpartum. CHW support included coaching on home BP monitoring and medication adherence; connections to WIC and food/diaper banks; education on APO risks, breastfeeding, and infant care; collaborative exercise, nutrition, and smoking cessation plans based on AHA Life's Essential 8; navigation support for postpartum appointments; and linkage to a primary care provider. CHWs contacted participants approximately twice weekly for weeks 1-4 and once weekly for weeks 5-12, in person or by telephone.
|
Usual Care
Participants received usual care including a validated blood pressure cuff, BP monitoring education, CVD-prevention coaching, and an educational handout on weight management, smoking cessation, nutrition/physical activity counseling, and breastfeeding coaching.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes
Baseline characteristics by cohort
| Measure |
Usual Care
n=31 Participants
Usual postpartum care
|
Usual Care and Community Health Worker Intervention
n=30 Participants
Usual postpartum care and community health worker visits and support
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 6.4 • n=20 Participants
|
28 years
STANDARD_DEVIATION 7.6 • n=20 Participants
|
29 years
STANDARD_DEVIATION 7.0 • n=40 Participants
|
|
Sex/Gender, Customized
Female
|
31 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=20 Participants
|
30 Participants
n=20 Participants
|
61 Participants
n=40 Participants
|
|
BMI at enrollment
|
36.5 kg/m squared
n=20 Participants
|
39.6 kg/m squared
n=20 Participants
|
38.7 kg/m squared
n=40 Participants
|
|
Insurance type (Gov't/Medicaid vs. Private)
Gov't/Medicaid
|
19 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
39 Participants
n=40 Participants
|
|
Insurance type (Gov't/Medicaid vs. Private)
Private
|
12 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
APO type
Preeclampsia
|
20 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
APO type
Gestational hypertension
|
9 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
APO type
Gestational diabetes
|
7 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
APO type
Small for gestational age infant
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Parity (multiparous yes/no)
Multiparous
|
21 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
Parity (multiparous yes/no)
Nulliparous
|
10 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.Population: Primary outcome assessed in the intervention arm only. Of 30 participants randomized to UC+CHW, 25 provided satisfaction ratings. Satisfaction ratings clustered at the top of the scale, yielding a median and IQR of 10.
Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10). Participant satisfaction with postpartum support received as part of the study, measured on a 1 to 10 scale where 1 = lowest satisfaction and 10 = highest satisfaction. Higher scores represent greater satisfaction (a better outcome).
Outcome measures
| Measure |
Usual Care
Usual postpartum care
|
Usual Care and Community Health Worker Intervention
n=25 Participants
Usual postpartum care and community health worker visits and support
|
|---|---|---|
|
Participant Satisfaction With Postpartum Support
|
—
|
10 units on a scale
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.Population: Assessed in the intervention arm only. Of 30 participants randomized to UC+CHW, 19 completed the validated acceptability questionnaire.
Patient satisfaction with CHW intervention using Sekhon Questionnaire to Assess the Acceptability of Healthcare Interventions, 1-5 scale with 1 being the lowest acceptability to 5 being the highest acceptability.
Outcome measures
| Measure |
Usual Care
Usual postpartum care
|
Usual Care and Community Health Worker Intervention
n=19 Participants
Usual postpartum care and community health worker visits and support
|
|---|---|---|
|
Patient Satisfaction With CHW Intervention
Positive feelings about CHW support
|
—
|
5 units on a scale
Interval 5.0 to 5.0
|
|
Patient Satisfaction With CHW Intervention
Self-efficacy managing complication with CHW help
|
—
|
5 units on a scale
Interval 5.0 to 5.0
|
SECONDARY outcome
Timeframe: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.Population: Among participants who had identified a PCP, 17 in the usual care group and 15 in the UC+CHW group reported on PCP appointment scheduling
Participant reports at least one visit is scheduled with a primary care provider
Outcome measures
| Measure |
Usual Care
n=17 Participants
Usual postpartum care
|
Usual Care and Community Health Worker Intervention
n=15 Participants
Usual postpartum care and community health worker visits and support
|
|---|---|---|
|
Primary Care Visit Scheduled
Scheduled a PCP appointment
|
11 Participants
|
12 Participants
|
|
Primary Care Visit Scheduled
Did not schedule a PCP appointment
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Measured at the in-person postpartum clinic visit, occurring anytime between 6 and 12 weeks postpartum.Population: Blood pressure was measured at the in-person postpartum visit. Of 31 UC and 30 UC+CHW participants, 22 in each group attended the postpartum visit and had BP measured
Mean systolic and diastolic blood pressure measured clinically at the in-person postpartum clinic visit occurring between 6 and 12 weeks postpartum. Reported as mean (standard deviation) in mmHg.
Outcome measures
| Measure |
Usual Care
n=22 Participants
Usual postpartum care
|
Usual Care and Community Health Worker Intervention
n=22 Participants
Usual postpartum care and community health worker visits and support
|
|---|---|---|
|
Mean Blood Pressure
Systolic blood pressure
|
134.0 mmHg
Standard Deviation 15.7
|
127.1 mmHg
Standard Deviation 13.4
|
|
Mean Blood Pressure
Diastolic
|
86.6 mmHg
Standard Deviation 11.4
|
83.9 mmHg
Standard Deviation 9.7
|
Adverse Events
Usual Care
Usual Care and Community Health Worker Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jesse Rattan, PhD, MPH, rN
University of Alabama at Birmingham Department of Obstetrics and Gynecology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place