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

Study Overview
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Brief Summary
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This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 2,600 Medi-Cal eligible pregnant women 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 lower rates of preterm birth, less depression and anxiety, and more respectful and greater satisfaction with prenatal care.

Official Title
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Comparing Approaches to Enhanced Prenatal Care to Improve Maternal and Child Health in Central CA

Conditions
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Premature Birth, Pregnancy Preterm, Prenatal Stress, Depression, Anxiety, Depression, Postpartum, Satisfaction, Patient, Health Problems in Pregnancy

Intervention / Treatment
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* Other: Glow! Group Prenatal Care
* Other: Individual Prenatal Care with CPSP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 8 and 20 weeks gestation at enrollment Eligible for Medi-Cal (at or below 213% of the federal poverty level) Speak English or Spanish 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glow! Group Prenatal Care<br>Group prenatal care with wrap around services. | Other: Glow! Group Prenatal Care<br>* Glow! is an enhanced group prenatal care model that offers co-located social services provided by established community programs with independent funding streams targeting low-income families. The Glow! group prenatal care model pairs a trained facilitator with a licensed prenatal care practitioner from a practice site to provide billable prenatal care to the practice's own patients. Over the course of 8-10 sessions, 10-12 women (within a 6- week gestational age range) receive prenatal medical care, risk assessments, and social support, and gain knowledge and skills related to pregnancy, birth, and parenting.<br>|
| Active Comparator: Individual Prenatal Care- CPSP<br>Individual prenatal care with supplemental services covered by CPSP. | Other: Individual Prenatal Care with CPSP<br>* Comprehensive Perinatal Services Program (CPSP) is a state-funded program for Medi-Cal eligible families to receive enhanced care and service coordination. Participants assigned to CPSP individual care may participate in the CPSP assessments with a Comprehensive Perinatal Health Worker at their prenatal care site, where individual prenatal care will be provided<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm birth | Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record. | 0-12 weeks after delivery | 
| Changes in depressive symptom severity | Changes in depressive symptom severity from baseline to postpartum. Assessed using the Patient Health Questionnaire (PHQ-9) developed by Kroenke et al. (2001), administered in-person at baseline and during telephone interview at three months postpartum. | Collected from study enrollment to three months postpartum | 
| Perceptions of respectful/disrespectful care | Extent to which the participant feels that the prenatal care they received was respectful. Assessed using the Mothers on Respect Index (MORi) developed by Vedam et al. (2017), administered during telephone interview or in-person at third trimester and three months postpartum. | Collected during third trimester and at three months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational age at delivery | The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record. | 0-12 weeks after delivery | 
| Changes in anxiety symptom severity | Changes in anxiety symptom severity from baseline to postpartum. Assessed using the 7-item Generalized Anxiety Disorder (GAD-7) scale developed by Spitzer et al. (2006), administered in-person at baseline and during telephone interview at three months postpartum. | Collected from study enrollment to three months postpartum | 
| Satisfaction with prenatal care | Extent to which the participant feels satisfied with the prenatal care they received. Assessed using the Prenatal Care Satisfaction (PSQ) Scale developed by Raube et al. (1998), administered during telephone interview or in-person interview at third trimester and three months postpartum. | Collected during third trimester and at three months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Birth, Group Prenatal Care, Respectful Care, Patient Satisfaction, Prenatal Depression and Anxiety, Low Income, Health Inequity, Prenatal Care