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).

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  • Additional Information
    • Source:
      Publisher: Elsevier Country of Publication: United States NLM ID: 101242342 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1559-2030 (Electronic) Linking ISSN: 15517144 NLM ISO Abbreviation: Contemp Clin Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: New York, N.Y. : Elsevier, c2005-
    • Subject Terms:
      Prenatal Care*/methods ; Prenatal Care*/organization & administration ; Poverty* ; Premature Birth*; Humans ; Female ; Pregnancy ; California ; Depression/therapy ; Adult ; Medicaid ; Comparative Effectiveness Research ; United States ; Infant, Newborn
    • Abstract:
      Background: 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.
      Methods: 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.
      Conclusions: 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.
      Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
      (Copyright © 2024 Elsevier Inc. All rights reserved.)
    • Contributed Indexing:
      Keywords: Anxiety; Depression; Postpartum depression; Pragmatic clinical trial; Pregnancy; Prenatal care; Preterm birth
    • Molecular Sequence:
      ClinicalTrials.gov NCT04154423
    • Publication Date:
      Date Created: 20240516 Date Completed: 20240727 Latest Revision: 20240727
    • Publication Date:
      20240729
    • Accession Number:
      10.1016/j.cct.2024.107568
    • Accession Number:
      38750950