Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
NCT04154423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 674
Last updated 2025-05-22
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.
Conditions
- Premature Birth
- Pregnancy Preterm
- Prenatal Stress
- Depression, Anxiety
- Depression, Postpartum
- Satisfaction, Patient
- Health Problems in Pregnancy
Interventions
- OTHER
-
Glow! Group Prenatal Care
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.
- OTHER
-
Individual Prenatal Care with CPSP
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
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
California State University, Fresno Foundation
collaborator OTHER -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Miriam Kuppermann, PhD, MPH · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-11-07
- Primary Completion
- 2024-12-23
- Completion
- 2024-12-23
Countries
- United States
Study Locations
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