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Completed

NCT Number: NCT04154423

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

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.

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Key information

Conditions

Premature Birth Anxiety Disorders Behavior Behavioral Symptoms Depression Depression, Anxiety Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Health Behavior Health Problems in Pregnancy Mental Disorders Mood Disorders Obstetric Labor Complications Obstetric Labor, Premature Patient Satisfaction Pregnancy Complications Pregnancy Preterm Prenatal Stress Puerperal Disorders Satisfaction, Patient Treatment Adherence and Compliance Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Central Valley Health Policy Institute, Fresno, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

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

Primary outcomes

  1. Changes in Patient Health Questionnaire (PHQ-9) Score

    Time frame: Collected from study enrollment to three months postpartum

    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.

  2. Person-centered prenatal care

    Time frame: Collected during third trimester

    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.

  3. Preterm birth

    Time frame: 0-12 weeks after delivery

    Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record.

Secondary outcomes

  1. Changes in anxiety symptom severity

    Time frame: Collected from study enrollment to three months postpartum

    Changes in anxiety symptom severity from baseline to postpartum. Assessed using the 7-item Generalized Anxiety Disorder (GAD-7) scale, administered in-person at baseline and during telephone interview at three months postpartum.

    The total scores range from 0-21 with higher scores indicating more severe anxiety.

  2. Perceptions of respectful/disrespectful maternity care

    Time frame: Collected at three months postpartum

    Extent to which the participant feels that the maternity care they received was respectful. Assessed using the Mothers on Respect Index (MORi), administered during telephone interview or in-person at third trimester and three months postpartum.

    The total scores range from 14-84 with higher scores indicating a higher level of respect.

  3. Satisfaction with prenatal care

    Time frame: Collected during third trimester and at three months postpartum

    Extent to which the participant feels satisfied with the prenatal care they received. Assessed using the Prenatal Care Satisfaction Scale, administered during telephone interview or in-person interview at third trimester and three months postpartum.

    The total scores range from 0-100 with higher scores indicating higher levels of satisfaction.

  4. Gestational age at delivery

    Time frame: 0-12 weeks after delivery

    The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.

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

    Time frame: 3 months postpartum

    Extent to which birthing person feels their prenatal and birthing experience was person centered, as measured by the Person-Centered Maternity Care scale.

    This measure focuses on the extent to which the participants feels their prenatal and maternity/birthing care was person centered.

    The title of the measure is Person Centered Maternity Care. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • California State University, Fresno Foundation
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: EMBRACE

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2019
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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