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| ID | Type | Description | Link |
|---|---|---|---|
| 24POST1198805 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| National Institutes of Health (NIH) | NIH |
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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.
The investigators will adapt a current perinatal community health worker intervention, lead by a leading community health worker organization, Connection Health, to the unique needs of Black postpartum patients with preeclampsia and other adverse pregnancy outcomes. The investigators will conduct a pilot trial to assess the feasibility and acceptability of the intervention. The hypothesis is that it is possible to randomize eligible patients to the feasibility trial, and the intervention will be acceptable to participants. The investigators will randomize Black postpartum patients with preeclampsia or other adverse pregnancy outcomes to either 1) usual care - cardiovascular disease-prevention education before discharge, or 2) intervention - cardiovascular disease prevention education before discharge plus an adapted Connection Health community health worker intervention. Following the completion of this project, the investigators intend to conduct a larger postpartum community health worker intervention trial in patients with preeclampsia or other adverse pregnancy outcomes powered to detect a difference in clinically meaningful outcomes, as informed by our existing community advisory board.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Experimental | Usual postpartum care |
|
| Usual care and community health worker intervention | Experimental | Usual postpartum care and community health worker visits and support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| usual postpartum care | Behavioral | Usual clinical and educational postpartum care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with CHW intervention | Patient satisfaction with CHW intervention using Sekhon Questionnaire to Assess the Acceptability of Healthcare Interventions, 1-5 scale with 1 being the lowest acceptability to 5 being the highest acceptability. | 6-12 weeks postpartum |
| Secondary Outcome Measure: Primary Care Visit Scheduled |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse E Rattan | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Medicine | Birmingham | Alabama | 35205 | United States | ||
| The University of Alabama at Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Centers for Disease Control and Prevention.Maternal Mortality by State, 2018. US Department of Health and Human Services. National Center for Health Statistics. | ||
| 33779213 | 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. | |
| 34455672 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 21, 2026 | |
| Reset | Jun 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 21, 2026 | Jun 17, 2026 | |||
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| usual postpartum care + community health worker intervention |
| Behavioral |
participants will receive routine care and also community health worker support and visits. |
|
Participant reports at least one visit is scheduled with a primary care provider |
| 6-12 weeks postpartum |
| Secondary Outcome Measure: Mean Blood Pressure | Mean blood pressure at 6-12 weeks postpartum | 6-12 weeks postpartum |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| 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. |
| 33573789 | 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. |
| 34905954 | 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. |