Trial Outcomes & Findings for Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study (NCT NCT04154423)
NCT ID: NCT04154423
Last Updated: 2026-08-17
Results Overview
Changes in depressive symptom severity from baseline to postpartum. Assessed using the Patient Health Questionnaire (PHQ-9), administered in-person at baseline and during telephone interview at three months postpartum. Total score ranges from 0-27 with higher scores indicating more severe depression.
COMPLETED
NA
678 participants
Collected from study enrollment to three months postpartum
2026-08-17
Participant Flow
678 were enrolled in the study, but 4 dropped out and requested that none of their data be used in analysis.
Participant milestones
| Measure |
Glow! Group Prenatal Care
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Overall Study
STARTED
|
298
|
380
|
|
Overall Study
COMPLETED
|
281
|
371
|
|
Overall Study
NOT COMPLETED
|
17
|
9
|
Reasons for withdrawal
| Measure |
Glow! Group Prenatal Care
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Provider withdrew from study
|
13
|
9
|
Baseline Characteristics
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
Baseline characteristics by cohort
| Measure |
Glow! Group Prenatal Care
n=281 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=371 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
Total
n=652 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.5 Years
STANDARD_DEVIATION 5.6 • n=51 Participants
|
27.3 Years
STANDARD_DEVIATION 5.9 • n=51 Participants
|
27.0 Years
STANDARD_DEVIATION 5.8 • n=102 Participants
|
|
Sex: Female, Male
Female
|
281 Participants
n=51 Participants
|
371 Participants
n=51 Participants
|
652 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
20 Participants
n=51 Participants
|
28 Participants
n=51 Participants
|
48 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Bi-or multi-racial/ethnic
|
18 Participants
n=51 Participants
|
18 Participants
n=51 Participants
|
36 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Latine
|
195 Participants
n=51 Participants
|
275 Participants
n=51 Participants
|
470 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
White
|
37 Participants
n=51 Participants
|
36 Participants
n=51 Participants
|
73 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=51 Participants
|
13 Participants
n=51 Participants
|
24 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=51 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=102 Participants
|
PRIMARY outcome
Timeframe: Collected from study enrollment to three months postpartumPopulation: Changes in PHQ-9 score data were not available for N=46 participants in the Group Prenatal Care arm and N=53 participants in the Individual Prenatal Care arm. Multiple imputation was used to impute the change in PHQ-9 score data for these participants.
Changes in depressive symptom severity from baseline to postpartum. Assessed using the Patient Health Questionnaire (PHQ-9), administered in-person at baseline and during telephone interview at three months postpartum. Total score ranges from 0-27 with higher scores indicating more severe depression.
Outcome measures
| Measure |
Glow! Group Prenatal Care
n=294 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=380 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Changes in Patient Health Questionnaire (PHQ-9) Score
|
-2.08 Scores on a scale
Standard Deviation 5.19
|
-1.44 Scores on a scale
Standard Deviation 4.16
|
PRIMARY outcome
Timeframe: Collected during third trimesterPopulation: Person-centered prenatal care data were not available for N=99 participants in the Group Prenatal Care arm and N=121 participants in the Individual Prenatal Care arm. Multiple imputation was used to impute the Person-centered prenatal care data for these participants.
This outcome focuses on the extent to which the participants feels their prenatal care was person centered. The title of the measure is Person Centered Prenatal Care (primary). This measurement tool is a questionnaire that includes series of items that were developed in collaboration with community members to measure their experience of care. In addition to the overall score, the scale includes three subscales identified as important by community members: dignity and respect, communication and autonomy, and responsive and supportive care. The measures have been validated in several languages. The total scores range from 0-100 with higher scores indicating the receipt of more person centered care.
Outcome measures
| Measure |
Glow! Group Prenatal Care
n=294 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=380 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Person-centered Prenatal Care
|
92.70 Scores on a scale
Standard Deviation 10.16
|
90.70 Scores on a scale
Standard Deviation 11.81
|
PRIMARY outcome
Timeframe: 0-12 weeks after deliveryPopulation: Preterm birth data were not available for N=16 participants in the Group Prenatal Care arm and N=27 participants in the Individual Prenatal Care arm. Multiple imputation was used to impute preterm data for these participants.
Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record.
Outcome measures
| Measure |
Glow! Group Prenatal Care
n=294 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=380 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Preterm Birth
|
23 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Collected from study enrollment to three months postpartumPopulation: Change in anxiety data were not available for N=44 participants in the Group Prenatal Care arm and N=52 participants in the Individual Prenatal Care arm. Multiple imputation was used to impute change in anxiety data for these participants.
Changes in anxiety symptom severity from baseline to postpartum. Assessed using the 7-item Generalized Anxiety Disorder (GAD-7) scale, administered in-person at baseline and during telephone interview at three months postpartum. The total scores range from 0-21 with higher scores indicating more severe anxiety.
Outcome measures
| Measure |
Glow! Group Prenatal Care
n=294 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=380 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Changes in Anxiety Symptom Severity
|
-0.54 Scores on a scale
Standard Deviation 4.59
|
-0.39 Scores on a scale
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: Collected at three months postpartumPopulation: Perceptions of respectful/disrespectful maternity care data were not available for N=58 participants in the Group Prenatal Care arm and N=67 participants in the Individual Prenatal Care arm. Multiple imputation was used to impute perceptions of respectful/disrespectful maternity care data for these participants.
Extent to which the participant feels that the maternity care they received was respectful. Assessed using the Mothers on Respect Index (MORi), administered during telephone interview or in-person at three months postpartum. The total scores range from 14-100 with higher scores indicating a higher level of respect.
Outcome measures
| Measure |
Glow! Group Prenatal Care
n=294 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=380 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Perceptions of Respectful/Disrespectful Maternity Care
|
85.94 Scores on a scale
Standard Deviation 12.63
|
85.27 Scores on a scale
Standard Deviation 11.18
|
SECONDARY outcome
Timeframe: Collected during third trimesterPopulation: Satisfaction with prenatal care data at third trimester were not available for N=62 participants in the Group Prenatal Care arm and N=88 participants in the Individual Prenatal Care arm. Multiple imputation was used to impute satisfaction with prenatal care data at third trimester for these participants.
Extent to which the participant feels satisfied with the prenatal care they received. Assessed using the Prenatal Care Satisfaction Scale, administered during telephone interview or in-person interview at third trimester. The total scores range from 0-100 with higher scores indicating higher levels of satisfaction.
Outcome measures
| Measure |
Glow! Group Prenatal Care
n=294 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=380 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Satisfaction With Prenatal Care
|
70.96 Scores on a scale
Standard Deviation 20.47
|
67.21 Scores on a scale
Standard Deviation 20.11
|
SECONDARY outcome
Timeframe: 0-12 weeks after deliveryPopulation: Gestational age data were not available for N=62 participants in the Group Prenatal Care arm and N=88 participants in the Individual Prenatal Care arm. Multiple imputation was used to impute gestational age data for these participants.
The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.
Outcome measures
| Measure |
Glow! Group Prenatal Care
n=294 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=380 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Gestational Age at Delivery
|
38.7 Weeks
Standard Deviation 2.3
|
38.7 Weeks
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 3 months postpartumPopulation: Person Centered Maternity Care data were not available for N=98 participants in the Group Prenatal Care arm and N=113 participants in the Individual Prenatal Care arm. Multiple imputation was used to impute Person Centered Maternity Care data for these participants.
Extent to which birthing person feels their prenatal and birthing experience was person centered, as measured by the Person-Centered Maternity Care scale. This measure focuses on the extent to which the participants feels their prenatal and maternity/birthing care was person centered. The title of the measure is Person Centered Maternity Care. This measurement tool is a questionnaire that includes series of items that were developed in collaboration with community members to measure their experience of care. In addition to the overall score, the scale includes three subscales identified as important by community members: dignity and respect, communication and autonomy, and responsive and supportive care. The measures have been validated in several languages. The total scores range from 0-100 with higher scores indicating the receipt of more person centered care.
Outcome measures
| Measure |
Glow! Group Prenatal Care
n=294 Participants
Group prenatal care with wrap around services.
|
Individual Prenatal Care- CPSP
n=380 Participants
Individual prenatal care with supplemental services covered by CPSP.
|
|---|---|---|
|
Person Centered Maternity Care
|
91.24 Scores on a scale
Standard Deviation 11.83
|
91.02 Scores on a scale
Standard Deviation 12.36
|
Adverse Events
Glow! Group Prenatal Care
Individual Prenatal Care- CPSP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Miriam Kupperman, PhD, MPH
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place