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Planning for the forgotten fourth trimester of pregnancy: A parallel group randomized control trial to test a postpartum planning intervention vs. standard prenatal care.

Authors :
Stanhope KK
Stallworth T
Forrest AD
Vuncannon D
Juarez G
Boulet SL
Geary F
Dunlop AL
Blake SC
Green VL
Jamieson DJ
Source :
Contemporary clinical trials [Contemp Clin Trials] 2024 Aug; Vol. 143, pp. 107586. Date of Electronic Publication: 2024 Jun 03.
Publication Year :
2024

Abstract

Background: Black and brown birthing people experience persistent disparities in adverse maternal health outcomes, partially due to inadequate perinatal care. The goal of this study is to design and evaluate a patient-centered intervention for obstetric patients with one or more cardiometabolic risk factors for severe maternal morbidity [gestational diabetes, diabetes mellitus, hypertensive disorders of pregnancy (chronic hypertension, preeclampsia, eclampsia, or gestational hypertension), or preconception obesity (BMI > 30)] to promote postpartum visit attendance.<br />Methods: To address identified unmet needs for postpartum support and barriers to postpartum care, we developed 20 thematic postpartum planning modules, each with corresponding patient educational materials, community resources, care coordination protocols, and clinician support tools (decision aids, electronic medical record prompts and fields). During prenatal care encounters, a research coordinator delivers the educational content (in English or Spanish), facilitates the participant's planning and shared decision-making, provides the participant with resources, and documents decisions in the electronic medical record. We will randomize 320 eligible patients with a 1:1 ratio to the intervention or standard prenatal care and evaluate the impact on postpartum visit attendance at 4-12 weeks and secondary outcomes (postpartum mental health, perceived future maternal and cardiometabolic risk, contraceptive use, primary care use, readmission, and patient satisfaction with care).<br />Discussion: Through engagement with patients and community stakeholders, we developed a guideline-based, locally tailored intervention to address drivers of engagement with postpartum care for high-risk obstetric patients. If demonstrated to be effective, the educational materials and electronic medical record based-tool can be adapted to other settings.<br />Trial Registration: This trial was registered on ClinicalTrials.gov (NCT05430815) on June 23, 2022.<br />Competing Interests: Declaration of competing interest This study is funded by the National Institute of Minority Health and Health Disparities (R01MD016031) and registered under clinicaltrials.gov (NCT05430815). It received ethical approval from the Emory University Institutional Review Board (00001427). All participating individuals completed informed consent prior to participation in the study. The NIMHD has no role in the conduct, analysis, or interpretation of results. We have no competing interests to declare.<br /> (Copyright © 2024 Elsevier Inc. All rights reserved.)

Details

Language :
English
ISSN :
1559-2030
Volume :
143
Database :
MEDLINE
Journal :
Contemporary clinical trials
Publication Type :
Academic Journal
Accession number :
38838985
Full Text :
https://doi.org/10.1016/j.cct.2024.107586