Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study (EMBRACE)
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|ClinicalTrials.gov Identifier: NCT04154423|
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : August 11, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2600 participants|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Miriam Kuppermann, PhD, MPH||(415) email@example.com|
|Contact: Lauren Lessard, PhD, MPHfirstname.lastname@example.org|
|Principal Investigator:||Miriam Kuppermann, PhD, MPH||University of California, San Francisco|
|Principal Investigator:||Lauren Lessard, PhD, MPH||California State University, Fresno|