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

NCT04154423 | Completed

• 1 other identifier: AD-2018C2-13227
• Study Type: interventional
• Target: 674
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Premature Birth; Group Prenatal Care; Respectful Care; Patient Satisfaction; Prenatal Depression and Anxiety; Low Income; Health Inequity; Prenatal Care; Person-Centered Care

Outcome Measures

Primary Outcomes (3)

• Changes in Patient Health Questionnaire (PHQ-9) Score

  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.

  Collected from study enrollment to three months postpartum

• Person-centered prenatal care

  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.

  Collected during third trimester

• 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

Secondary Outcomes (5)

• Changes in anxiety symptom severity

  Collected from study enrollment to three months postpartum

• Perceptions of respectful/disrespectful maternity care

  Collected at three months postpartum

• Satisfaction with prenatal care

  Collected during third trimester and at three months postpartum

• Gestational age at delivery

  0-12 weeks after delivery

• Person Centered Maternity Care as measured at 3 months postpartum.

  3 months postpartum

Study Arms (2)

Glow! Group Prenatal Care

ACTIVE COMPARATOR

Group prenatal care with wrap around services.

Other: Glow! Group Prenatal Care

Individual Prenatal Care- CPSP

ACTIVE COMPARATOR

Individual prenatal care with supplemental services covered by CPSP.

Other: Individual Prenatal Care with CPSP

Interventions

Glow! Group Prenatal Care OTHER

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.

Glow! Group Prenatal Care

Individual Prenatal Care with CPSP OTHER

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

Individual Prenatal Care- CPSP

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Patient-Centered Outcomes Research Institute: collaborator
• California State University, Fresno Foundation: collaborator

Study Sites (2)

Central Valley Health Policy Institute

Fresno, California, 93710, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (8)

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Raube K, Handler A, Rosenberg D. Measuring satisfaction among low-income women: a prenatal care questionnaire. Matern Child Health J. 1998 Mar;2(1):25-33. doi: 10.1023/a:1021841508698.

  PMID: 10728256 BACKGROUND

• Vedam S, Stoll K, Rubashkin N, Martin K, Miller-Vedam Z, Hayes-Klein H, Jolicoeur G; CCinBC Steering Council. The Mothers on Respect (MOR) index: measuring quality, safety, and human rights in childbirth. SSM Popul Health. 2017 Jan 19;3:201-210. doi: 10.1016/j.ssmph.2017.01.005. eCollection 2017 Dec.

  PMID: 29349217 BACKGROUND

• Peek ME, Nunez-Smith M, Drum M, Lewis TT. Adapting the everyday discrimination scale to medical settings: reliability and validity testing in a sample of African American patients. Ethn Dis. 2011 Autumn;21(4):502-9.

  PMID: 22428358 BACKGROUND

• Krieger N, Smith K, Naishadham D, Hartman C, Barbeau EM. Experiences of discrimination: validity and reliability of a self-report measure for population health research on racism and health. Soc Sci Med. 2005 Oct;61(7):1576-96. doi: 10.1016/j.socscimed.2005.03.006. Epub 2005 Apr 21.

  PMID: 16005789 BACKGROUND

• Kuppermann M, Pressman A, Coleman-Phox K, Afulani P, Blebu B, Carraway K, Butcher BC, Curry V, Downer C, Edwards B, Felder JN, Fontenot J, Garza MA, Karasek D, Lessard L, Martinez E, McCulloch CE, Oberholzer C, Ramirez GR, Tesfalul M, Wiemann A. 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). Contemp Clin Trials. 2024 Aug;143:107568. doi: 10.1016/j.cct.2024.107568. Epub 2024 May 14.

  PMID: 38750950 DERIVED

• Felder JN, Afulani PA, Coleman-Phox K, Omowale SS, McCulloch CE, Lessard L, Kuppermann M. Pregnancy-related COVID worry, depressive symptom severity, and mediation through sleep disturbance in a low-income, primarily Latinx population in California's Central valley. J Psychiatr Res. 2023 Jan;157:96-103. doi: 10.1016/j.jpsychires.2022.11.019. Epub 2022 Nov 23.

  PMID: 36459760 DERIVED

MeSH Terms

Conditions

Premature Birth; Depression; Anxiety Disorders; Depression, Postpartum; Patient Satisfaction

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Puerperal Disorders; Depressive Disorder; Mood Disorders; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Miriam Kuppermann, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 6, 2019
• Study Start: November 7, 2019
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)