A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes

NCT06353256 | Completed

• 2 other identifiers: 30001260724POST1198805
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

United States maternal mortality and preterm birth rates are among the highest among high-income countries due in part to a combination of racial, regional and socioeconomic disparities in access to care and overall health. The research proposed focuses on adapting and expanding a perinatal community health worker intervention for Black postpartum patients with preeclampsia (PE) and other adverse pregnancy outcomes (APOs). Investigators will partner with a community-based organization that trains and deploys community health workers. Investigators will test an intervention for urban and rural Black postpartum patients with APOs to 1) enhance blood pressure control postpartum and 2) promote long-term cardiovascular disease prevention for this underserved population. This pilot study will determine if randomizing and implementing a community health worker intervention tailored to pregnant people experiencing preeclampsia is feasible and found to be acceptable by participants.

Conditions

Preeclampsia Postpartum; Adverse Pregnancy Outcomes

Keywords

community health workers; adverse pregnancy outcomes; preeclampsia

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10).

  12 weeks

Secondary Outcomes (3)

• Patient satisfaction with CHW intervention

  6-12 weeks postpartum

• Secondary Outcome Measure: Primary Care Visit Scheduled

  6-12 weeks postpartum

• Secondary Outcome Measure: Mean Blood Pressure

  6-12 weeks postpartum

Study Arms (2)

Usual Care

EXPERIMENTAL

Usual postpartum care

Behavioral: usual postpartum care

Usual care and community health worker intervention

EXPERIMENTAL

Usual postpartum care and community health worker visits and support

Behavioral: usual postpartum care + community health worker intervention

Interventions

usual postpartum care BEHAVIORAL

Usual clinical and educational postpartum care

Usual Care

usual postpartum care + community health worker intervention BEHAVIORAL

participants will receive routine care and also community health worker support and visits.

Usual care and community health worker intervention

Eligibility Criteria

• Age: 16 Years - 56 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Self Identifies as Black
• Between 16-56 years old
• Experiencing adverse pregnancy outcomes defined as hypertensive disorders of pregnancy, preterm birth, placental abruption, pregnancy loss (loss at greater or equal to 14 weeks gestation), gestational diabetes, delivering a small for gestational age infant
• Planning to deliver at UAB Hospital
• Speaks and writes in English

You may not qualify if:

• Declines Randomization
• Speaks or writes in languages other than English
• Currently incarcerated
• Previously enrolled in P3OPPY

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Heart Association: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (2)

UAB Medicine

Birmingham, Alabama, 35205, United States

Location

The University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (5)

• Centers for Disease Control and Prevention.Maternal Mortality by State, 2018. US Department of Health and Human Services. National Center for Health Statistics.

  BACKGROUND

• Parikh NI, Gonzalez JM, Anderson CAM, Judd SE, Rexrode KM, Hlatky MA, Gunderson EP, Stuart JJ, Vaidya D; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and the Stroke Council. Adverse Pregnancy Outcomes and Cardiovascular Disease Risk: Unique Opportunities for Cardiovascular Disease Prevention in Women: A Scientific Statement From the American Heart Association. Circulation. 2021 May 4;143(18):e902-e916. doi: 10.1161/CIR.0000000000000961. Epub 2021 Mar 29.

  PMID: 33779213 BACKGROUND

• Leitao S, Manning E, Greene RA, Corcoran P; Maternal Morbidity Advisory Group*. Maternal morbidity and mortality: an iceberg phenomenon. BJOG. 2022 Feb;129(3):402-411. doi: 10.1111/1471-0528.16880. Epub 2021 Sep 23.

  PMID: 34455672 BACKGROUND

• Minehart RD, Bryant AS, Jackson J, Daly JL. Racial/Ethnic Inequities in Pregnancy-Related Morbidity and Mortality. Obstet Gynecol Clin North Am. 2021 Mar;48(1):31-51. doi: 10.1016/j.ogc.2020.11.005.

  PMID: 33573789 BACKGROUND

• Garovic VD, Dechend R, Easterling T, Karumanchi SA, McMurtry Baird S, Magee LA, Rana S, Vermunt JV, August P; American Heart Association Council on Hypertension; Council on the Kidney in Cardiovascular Disease, Kidney in Heart Disease Science Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; and Stroke Council. Hypertension in Pregnancy: Diagnosis, Blood Pressure Goals, and Pharmacotherapy: A Scientific Statement From the American Heart Association. Hypertension. 2022 Feb;79(2):e21-e41. doi: 10.1161/HYP.0000000000000208. Epub 2021 Dec 15.

  PMID: 34905954 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jesse E Rattan

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: September 3, 2024
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)