A randomized comparative-effectiveness study of two enhanced prenatal care models for low-income pregnant people: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE).

Anxiety Depression Postpartum depression Pragmatic clinical trial Pregnancy Prenatal care Preterm birth

Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
13 May 2024
Historique:
received: 21 11 2023
revised: 18 04 2024
accepted: 04 05 2024
medline: 16 5 2024
pubmed: 16 5 2024
entrez: 16 5 2024
Statut: aheadofprint

Résumé

Improving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. Recently, an enhanced group prenatal care program, "Glow! Group Prenatal Care and Support," was developed in California's Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes. Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medicaid-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health's Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant's third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials. This comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use. ClinicalTrials.gov: NCT04154423.

Sections du résumé

BACKGROUND BACKGROUND
Improving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. Recently, an enhanced group prenatal care program, "Glow! Group Prenatal Care and Support," was developed in California's Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes.
METHODS METHODS
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medicaid-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health's Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant's third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials.
CONCLUSIONS CONCLUSIONS
This comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov: NCT04154423.

Identifiants

DOI: 10.1016/j.cct.2024.107568 PMID: 38750950
pubmed: 38750950
pii: S1551-7144(24)00151-4
doi: 10.1016/j.cct.2024.107568
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04154423']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

107568

Informations de copyright

Copyright © 2024. Published by Elsevier Inc.

Auteurs

Miriam Kuppermann (M)

University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America. Electronic address: miriam.kuppermann@ucsf.edu.

Alice Pressman (A)

Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America.

Kimberly Coleman-Phox (K)

University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America.

Patience Afulani (P)

University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco, CA, United States of America; Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America.

Bridgette Blebu (B)

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States of America.

Kristin Carraway (K)

Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America.

Brittany Chambers Butcher (BC)

Department of Human Ecology, College of Agricultural and Environmental Sciences, University of California, Davis, Davis, CA, United States of America.

Venise Curry (V)

Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America.

Chris Downer (C)

Medical Education Program, University of California, San Francisco, Fresno, CA, United States of America.

Brittany Edwards (B)

Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America.

Jennifer N Felder (JN)

Department of Psychiatry and Behavioral Sciences, University of California, San Francisco, CA, United States of America.

Jazmin Fontenot (J)

University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America.

Mary A Garza (MA)

Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America; Department of Public Health, College of Health and Human Services, California State University, Fresno, Fresno, CA, United States of America.

Deborah Karasek (D)

University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America.

Lauren Lessard (L)

Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America; Institute for Circumpolar Health Studies, University of Alaska, Anchorage, Anchorage, AK, United States of America.

Erica Martinez (E)

Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America.

Charles E McCulloch (CE)

Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, United States of America.

Christy Oberholzer (C)

Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America.

Guadalupe R Ramirez (GR)

Children and Families Commission of Fresno County, Fresno, CA, United States of America.

Martha Tesfalul (M)

University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences, San Francisco, CA, United States of America; The California Preterm Birth Initiative, University of California, San Francisco, San Francisco, CA, United States of America.

Andrea Weimann (A)

Central Valley Health Policy Institute, California State University, Fresno, Fresno, CA, United States of America.

Classifications MeSH