Preeclampsia PostpartumAW2HNCT06353256
A Community Health Worker Intervention to Address Adverse Pregnancy Outcomes
A study testing usual postpartum care and usual postpartum care + community health worker intervention in people with Preeclampsia Postpartum and Adverse Pregnancy Outcomes, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 56 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia Postpartum, Adverse Pregnancy Outcomes
- What is being tested?
- usual postpartum care and usual postpartum care + community health worker intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2024to 2 Jun 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 56 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Declines Randomization
- Speaks or writes in languages other than English
- Currently incarcerated
- Previously enrolled in P3OPPY
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UAB Medicine
Birmingham, Alabama, 35205
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Alabama Womb 2 Heart Solution (AW2H): A Community Health Worker Intervention to Improve Short- and Long-term Outcomes in Black Patients With Adverse Pregnancy Outcomes
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.
Read the detailed description
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.
- Being tested
- usual postpartum care, usual postpartum care + community health worker intervention
- Keywords
- community health workers, adverse pregnancy outcomes, preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual postpartum careBehavioural
Usual clinical and educational postpartum care
usual postpartum care + community health worker interventionBehavioural
participants will receive routine care and also community health worker support and visits.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Experimental | Usual postpartum care Receives: Behavioral: usual postpartum care |
| Usual care and community health worker intervention | Experimental | Usual postpartum care and community health worker visits and support Receives: Behavioral: usual postpartum care + community health worker intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction With Postpartum Support
Participant satisfaction with postpartum support received as part of the study (scaled from 1 to 10). Participant satisfaction with postpartum support received as part of the study, measured on a 1 to 10 scale where 1 = lowest satisfaction and 10 = highest satisfaction. Higher scores represent greater satisfaction (a better outcome).
Measured: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.
Secondary outcomes (3)
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.
Measured: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.
Primary Care Visit Scheduled
Participant reports at least one visit is scheduled with a primary care provider
Measured: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.
Mean Blood Pressure
Mean systolic and diastolic blood pressure measured clinically at the in-person postpartum clinic visit occurring between 6 and 12 weeks postpartum. Reported as mean (standard deviation) in mmHg.
Measured: Measured at the in-person postpartum clinic visit, occurring anytime between 6 and 12 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start3 Sep 2024
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preeclampsia PostpartumStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jesse Rattan, University of Alabama at Birmingham
- Investigators
- Jesse E Rattan, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353256
- Sponsor's protocol ID
- 300012607
- Other IDs
- 24POST1198805
- Acronym
- AW2H
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2024
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Centers for Disease Control and Prevention.Maternal Mortality by State, 2018. US Department of Health and Human Services. National Center for Health Statistics.
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.
PubMed 33779213Leitao 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.
PubMed 34455672Minehart 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.
PubMed 33573789Garovic 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.
PubMed 34905954Rattan JE, Benson KT, Ashford TH, Miller SM, Shukla VV, Travers CP, Toluhi AA, Richardson MB, Longenecker CT, Tita AT, Carlo WA, Sinkey RG. Blending insights and evidence: Co-creating a community health worker intervention for postpartum patients with preeclampsia. Pregnancy (Hoboken). 2025 Aug 22;1(5):e70084. doi: 10.1002/pmf2.70084. eCollection 2025 Sep.
PubMed 42597096