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)

• Published in: Contemporary clinical trials Vol. 143; p. 107568
• Main Authors: Kuppermann, Miriam, Pressman, Alice, Coleman-Phox, Kimberly, Afulani, Patience, Blebu, Bridgette, Carraway, Kristin, Butcher, Brittany Chambers, Curry, Venise, Downer, Chris, Edwards, Brittany, Felder, Jennifer N., Fontenot, Jazmin, Garza, Mary A., Karasek, Deborah, Lessard, Lauren, Martinez, Erica, McCulloch, Charles E., Oberholzer, Christy, Ramirez, Guadalupe R., Tesfalul, Martha, Wiemann, Andrea
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2024
• Subjects: Adult; Anxiety; California; Comparative Effectiveness Research; Depression; Depression - therapy; Female; Humans; Infant, Newborn; Medicaid; Postpartum depression; Poverty; Pragmatic clinical trial; Pregnancy; Premature Birth; Prenatal care; Prenatal Care - methods; Prenatal Care - organization & administration; Preterm birth; United States; United States; California; PCS; Preterm birth; PCPC; UCSF; PHQ-9; EHR; EMBRACE; IQFP; GAD-7; CPSP; mMOS; HIPAA; Anxiety; MORi; PROMIS; FSS; Depression; PCMC; Prenatal care; CFBP; Pregnancy; Pragmatic clinical trial; PSS; PCORI; HTE; IRB; Postpartum depression; PTB
• ISSN: 1551-7144; 1559-2030; 1559-2030
• DOI: 10.1016/j.cct.2024.107568

Improving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. An enhanced group prenatal care program, “Glow! Group Prenatal Care and Support,” was developed in California's Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes. Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medi-Cal (California's Medicaid program)-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health's Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant's third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials. This comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use. Trial Registration: ClinicalTrials.gov: NCT04154423.