Premature BirthEMBRACENCT04154423
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
A study testing Glow! Group Prenatal Care and Individual Prenatal Care with CPSP in people with Premature Birth and Pregnancy Preterm, run by University of California, San Francisco at 2 sites in United States.
Trial summary
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Pregnancy Preterm, Prenatal Stress
- What is being tested?
- Glow! Group Prenatal Care and Individual Prenatal Care with CPSP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 678 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2019to 23 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unavailable to attend group prenatal care sessions
- Not planning to continue prenatal care with site provider
- Cannot legally consent to participate in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Valley Health Policy Institute
Fresno, California, 93710
UCSF
San Francisco, California, 94143
About this study
Official title: Comparing Approaches to Enhanced Prenatal Care to Improve Maternal and Child Health in Central CA
This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 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
- Being tested
- Glow! Group Prenatal Care, Individual Prenatal Care with CPSP
- Keywords
- Premature Birth, Group Prenatal Care, Respectful Care, Patient Satisfaction, Prenatal Depression and Anxiety, Low Income, Health Inequity, Prenatal Care, Person-Centered Care
- Medical subject headings
- Premature Birth, Depression, Anxiety Disorders, Depression, Postpartum, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glow! Group Prenatal CareOther
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 CPSPOther
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
| Study group | Role | What they receive |
|---|---|---|
| Glow! Group Prenatal Care | Active comparator | Group prenatal care with wrap around services. Receives: Other: Glow! Group Prenatal Care |
| Individual Prenatal Care- CPSP | Active comparator | Individual prenatal care with supplemental services covered by CPSP. Receives: Other: Individual Prenatal Care with CPSP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0-12 weeks after delivery
Secondary outcomes (5)
Changes in Anxiety Symptom Severity
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.
Measured: Collected from study enrollment to three months postpartum
Perceptions of Respectful/Disrespectful Maternity Care
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 three months postpartum.
The total scores range from 14-100 with higher scores indicating a higher level of respect.
Measured: Collected at three months postpartum
Satisfaction With Prenatal Care
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.
The total scores range from 0-100 with higher scores indicating higher levels of satisfaction.
Measured: Collected during third trimester
Gestational Age at Delivery
The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.
Measured: 0-12 weeks after delivery
Person Centered Maternity Care
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.
Measured: 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start7 Nov 2019
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 678 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, California State University, Fresno Foundation
- Responsible party
- Sponsor
- Investigators
- Miriam Kuppermann, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154423
- Sponsor's protocol ID
- AD-2018C2-13227
- Acronym
- EMBRACE
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2019
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11556941Spitzer 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.
PubMed 16717171Raube 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.
PubMed 10728256Vedam 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.
PubMed 29349217Peek 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.
PubMed 22428358Krieger 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.
PubMed 16005789Afulani PA, Leon-Martinez D, Carraway K, Curry VC, Chambers Butcher BD, Simard B, Blat C, Coleman-Phox K, Blebu BE, Felder JN, Karasek D, Tesfalul MA, Garza MA, Mcculloch CE, Kuppermann M. Comparative Effect of Two Enhanced Prenatal Care Models on Care Experiences: A Randomized Controlled Trial. Obstet Gynecol. 2026 Jul 1;148(1):121-131. doi: 10.1097/AOG.0000000000006237. Epub 2026 Mar 12.
PubMed 41818754Felder JN, Leon-Martinez D, Karasek D, Curry V, Carraway K, Afulani PA, Blebu B, Chambers-Butcher B, Coleman-Phox K, Simard BJ, Blat C, Garza MA, McCulloch CE, Kuppermann M. Enhanced Prenatal Care Models and Postpartum Depression: The EMBRACE Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2559883. doi: 10.1001/jamanetworkopen.2025.59883.
PubMed 41697697Keeton VF, Leon-Martinez D, Robles DC, Martinez E, Lessard L, Garza MA, Kuppermann M, Chambers Butcher BD. Latina Women's Perinatal Experiences and Perspectives Around Discrimination, Anti-immigrant Policies, and Community Violence. J Obstet Gynecol Neonatal Nurs. 2024 Nov;53(6):635-647.e1. doi: 10.1016/j.jogn.2024.07.007. Epub 2024 Sep 7.
PubMed 39251084Kuppermann 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.
PubMed 38750950Felder 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.
PubMed 36459760