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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154423
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
California State University, Fresno
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 2,600 Medi-Cal eligible pregnant women 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 lower rates of preterm birth, less depression and anxiety, and more respectful and greater satisfaction with prenatal care.

Condition or disease Intervention/treatment Phase
Premature Birth Pregnancy Preterm Prenatal Stress Depression, Anxiety Depression, Postpartum Satisfaction, Patient Health Problems in Pregnancy Other: Glow! Group Prenatal Care Other: Individual Prenatal Care with CPSP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Comparing Approaches to Enhanced Prenatal Care to Improve Maternal and Child Health in Central CA
Actual Study Start Date : November 7, 2019
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Glow! Group Prenatal Care
Group prenatal care with wrap around services.
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.

Active Comparator: Individual Prenatal Care- CPSP
Individual prenatal care with supplemental services covered by CPSP.
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




Primary Outcome Measures :
  1. 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.

  2. Changes in depressive symptom severity [ 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) developed by Kroenke et al. (2001), administered in-person at baseline and during telephone interview at three months postpartum.

  3. Perceptions of respectful/disrespectful care [ Time Frame: Collected during third trimester and at three months postpartum ]
    Extent to which the participant feels that the prenatal care they received was respectful. Assessed using the Mothers on Respect Index (MORi) developed by Vedam et al. (2017), administered during telephone interview or in-person at third trimester and three months postpartum.


Secondary Outcome Measures :
  1. 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.

  2. 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 developed by Spitzer et al. (2006), administered in-person at baseline and during telephone interview at three months postpartum.

  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 (PCS) Scale developed by Raube et al. (1998), administered during telephone interview or in-person interview at third trimester and three months postpartum.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 8 and 20 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154423


Contacts
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Contact: Miriam Kuppermann, PhD, MPH (415) 502-4089 miriam.kuppermann@ucsf.edu
Contact: Lauren Lessard, PhD, MPH llessard@csufresno.edu

Locations
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United States, California
Central Valley Health Policy Institute Recruiting
Fresno, California, United States, 93710
Contact: Lauren Lessard, PhD, MPH       llessard@csufresno.edu   
Contact: Miriam Kuppermann, PhD, MPH       miriam.kuppermann@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
California State University, Fresno
Investigators
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Principal Investigator: Miriam Kuppermann, PhD, MPH University of California, San Francisco
Principal Investigator: Lauren Lessard, PhD, MPH California State University, Fresno
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04154423    
Other Study ID Numbers: AD-2018C2-13227
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Premature Birth
Group Prenatal Care
Respectful Care
Patient Satisfaction
Prenatal Depression and Anxiety
Low Income
Health Inequity
Prenatal Care
Additional relevant MeSH terms:
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Premature Birth
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders