Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study

Not Applicable

Recruiting

• Conditions: Pregnancy Preterm; Depression, Anxiety; Premature Birth; Depression, Postpartum; Health Problems in Pregnancy; Prenatal Stress; Satisfaction, Patient
• Interventions: Other: Glow! Group Prenatal Care; Other: Individual Prenatal Care with CPSP

• Registration Number: NCT04154423
• Lead Sponsor: University of California, San Francisco

Brief Summary

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 657 Medi-Cal eligible pregnant individuals in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in less depression and anxiety, and more respectful, more person-centered maternity care and lower rates of preterm birth.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Study Start: 2019-11-07
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 657

Inclusion Criteria

• Between 8 and 24 weeks gestation at enrollment
• Eligible for Medi-Cal (at or below 213% of the federal poverty level)
• Speak English or Spanish

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Exclusion Criteria

• Unavailable to attend group prenatal care sessions
• Not planning to continue prenatal care with site provider
• Cannot legally consent to participate in the study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glow! Group Prenatal Care	Glow! Group Prenatal Care	Group prenatal care with wrap around services.
Individual Prenatal Care- CPSP	Individual Prenatal Care with CPSP	Individual prenatal care with supplemental services covered by CPSP.

Primary Outcome Measures

Name	Time	Method
Preterm birth	0-12 weeks after delivery	Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record.
Person-centered prenatal care	Collected during third trimester	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.
Changes in Patient Health Questionnaire (PHQ-9) Score	Collected from study enrollment to three months postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Gestational age at delivery	0-12 weeks after delivery	The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.
Perceptions of respectful/disrespectful maternity care	Collected at three months postpartum	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 third trimester and three months postpartum.; The total scores range from 14-84 with higher scores indicating a higher level of respect.
Changes in anxiety symptom severity	Collected from study enrollment to three months postpartum	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.
Satisfaction with prenatal care	Collected during third trimester and at three months postpartum	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 and three months postpartum.; The total scores range from 0-100 with higher scores indicating higher levels of satisfaction.
Person Centered Maternity Care as measured at 3 months postpartum.	3 months postpartum	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.

Trial Locations

Locations (2)

UCSF; 🇺🇸 San Francisco, California, United States

Central Valley Health Policy Institute; 🇺🇸 Fresno, California, United States