Clinical trial NCT04154423: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
Official title: Comparing Approaches to Enhanced Prenatal Care to Improve Maternal and Child Health in Central CA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth
Pregnancy Preterm
Prenatal Stress
Depression, Anxiety
Depression, Postpartum
Satisfaction, Patient
Health Problems in Pregnancy
Keywords: Premature Birth
Group Prenatal Care
Respectful Care
Patient Satisfaction
Prenatal Depression and Anxiety
Low Income
Health Inequity
Prenatal Care
Person-Centered Care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: California State University, Fresno Foundation
First posted: 2019-11-06
Enrollment: 674
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Patient Health Questionnaire (PHQ-9) Score
timeFrame: Collected from study enrollment to three months postpartum
measure: Person-centered prenatal care
timeFrame: Collected during third trimester
measure: Preterm birth
timeFrame: 0-12 weeks after delivery
Secondary outcomes:
measure: Changes in anxiety symptom severity
timeFrame: Collected from study enrollment to three months postpartum
measure: Perceptions of respectful/disrespectful maternity care
timeFrame: Collected at three months postpartum
measure: Satisfaction with prenatal care
timeFrame: Collected during third trimester and at three months postpartum
measure: Gestational age at delivery
timeFrame: 0-12 weeks after delivery
measure: Person Centered Maternity Care as measured at 3 months postpartum.
timeFrame: 3 months postpartum
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Central Valley Health Policy Institute
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Miriam Kuppermann, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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citation: 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.