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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
usual postpartum care and usual postpartum care + community health worker intervention
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
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Other trials in United States

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 groups in NCT06353256
Study groupRoleWhat they receive
Usual CareExperimentalUsual postpartum care
Receives: Behavioral: usual postpartum care
Usual care and community health worker interventionExperimentalUsual 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.

  1. 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)

  1. 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.

  2. 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.

  3. 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.

  1. First posted9 Apr 2024
  2. Study start3 Sep 2024
  3. Primary completion2 Jun 2025
  4. Study completion2 Jun 2025

Resources

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)
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
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 33779213

  • 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.

    PubMed 34455672

  • 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.

    PubMed 33573789

  • 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.

    PubMed 34905954

  • Rattan 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Satisfaction With Postpartum Support (time frame: Assessed once at the study postpartum follow-up, which occurred approximately 12 to 20 weeks postpartum.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06353256, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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