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

NCT04154423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 674

Last updated 2025-05-22

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04154423 on ClinicalTrials.gov