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

Premature Birth Clinical Trial

— EMBRACE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04154423
• Other study ID #: AD-2018C2-13227
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2019
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2024
• Source: University of California, San Francisco
• Contact: Miriam Kuppermann, PhD, MPH
• Phone: (415) 502-4089
• Email: miriam.kuppermann[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 657
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety
• Depression, Postpartum
• Depressive Disorder
• Health Problems in Pregnancy
• Pregnancy Preterm
• Premature Birth
• Prenatal Stress
• Satisfaction, Patient

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Central Valley Health Policy Institute	Fresno	California
United States	UCSF	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	California State University, Fresno Foundation, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Collected from study enrollment to three months postpartum
Secondary	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 third trimester and three months postpartum.; The total scores range from 14-84 with higher scores indicating a higher level of respect.	Collected at three months postpartum
Secondary	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 and three months postpartum.; The total scores range from 0-100 with higher scores indicating higher levels of satisfaction.	Collected during third trimester and at three months postpartum
Secondary	Gestational age at delivery	The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.	0-12 weeks after delivery
Secondary	Person Centered Maternity Care as measured at 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.	3 months postpartum