Community Health Worker Support for Preeclampsia

(AW2H Trial)

No longer recruiting at 1 trial location

Overseen By Rachel Sinkey, MD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Non-English speakers, Incarceration, Previous P3OPPY

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a support program for Black postpartum patients who have experienced preeclampsia (a pregnancy complication with high blood pressure) or other pregnancy issues. The goal is to determine if community health workers can help control blood pressure after childbirth and reduce long-term heart disease risks. Participants will receive either usual postpartum care or additional visits and support from community health workers (Community Health Worker Intervention). This trial suits Black individuals who had complications like high blood pressure during pregnancy and plan to deliver at UAB Hospital. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve postpartum care and long-term health outcomes for Black patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this community health worker intervention is safe for postpartum patients with preeclampsia?

Research shows that community health worker programs are generally safe for participants. These programs involve trained community members who provide support and education to help patients manage their health. Although specific data on the safety of these programs for new mothers with preeclampsia is limited, they have been used in other health areas without major safety issues.

This trial examines whether community health workers can help control blood pressure and prevent long-term heart problems. The trial is in the "Not Applicable" phase, focusing on the program's practicality and acceptability rather than safety. However, since community health worker programs are widely used in healthcare, they are expected to be safe.

Overall, there is no direct evidence of harm from these programs, making them a potentially safe option for supporting new mothers with preeclampsia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of community health workers to provide vital support in managing preeclampsia, a condition that currently relies on standard postpartum care like regular monitoring and medication. Unlike typical treatments, this approach involves community health workers who offer personalized visits and support, potentially improving patient outcomes by addressing social and emotional needs alongside medical ones. This could lead to a more holistic and accessible way to manage preeclampsia, offering benefits beyond what conventional care can provide.

What evidence suggests that the Community Health Worker Intervention is effective for preeclampsia?

Research has shown that community health workers can effectively assist people with preeclampsia by improving their health. In this trial, participants will receive either usual postpartum care or usual care combined with community health worker intervention. One study involved individuals who experienced preeclampsia and found that personalized support from these workers helped manage blood pressure and prevent future heart issues. Another study discovered that including community health workers in care plans addressed the specific needs of new mothers, leading to better health management. These workers provide personalized advice, education, and support during the crucial postpartum period. Overall, this approach has shown promise in enhancing care for new mothers with preeclampsia. ^{5 6 7 8 9}

Who Is on the Research Team?

Jesse E Rattan

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for Black individuals between the ages of 16-56 who are experiencing adverse pregnancy outcomes like preeclampsia, preterm birth, and others. Participants must be planning to deliver at UAB Hospital, speak and write English, and not be due for delivery at enrollment.

Inclusion Criteria

I am between 16 and 56 years old.

Self Identifies as Black

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

Exclusion Criteria

I choose not to be randomly assigned to a treatment group.

Speaks or writes in languages other than English

Currently incarcerated

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive cardiovascular disease prevention education and community health worker support

12 weeks

Regular visits with community health workers

Follow-up

Participants are monitored for satisfaction and health outcomes, including blood pressure and primary care visit scheduling

6-12 weeks postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker Intervention

Trial Overview The study is testing if adding a community health worker intervention to usual postpartum care can better control blood pressure after childbirth and help prevent heart disease later on in Black patients with adverse pregnancy outcomes.

How Is the Trial Designed?

Group I: Usual care and community health worker intervention Experimental Treatment 2 Interventions

Usual postpartum care and community health worker visits and support

Group II: Usual Care Experimental Treatment 1 Intervention

Usual postpartum care

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The CLIP trial, involving 39,446 women, aimed to reduce maternal and perinatal mortality through community engagement by Lady Health Workers, but did not show a significant difference in overall adverse outcomes between intervention and control groups.

While the intervention did lead to a reduction in stillbirths, it had no significant impact on maternal deaths or morbidity, suggesting that improvements in community outreach need to be paired with enhanced healthcare facility support for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial. Qureshi, RN., Sheikh, S., Hoodbhoy, Z., et al.[2021]

Community Health Workers (CHWs) who received enhanced training and support were 15% more likely to fully immunize their clients and 14% more likely to ensure that clients completed four or more antenatal care visits, indicating the effectiveness of the intervention in improving health outcomes.

The study found that recent training and experience with pregnant women significantly increased CHW knowledge, while education and literacy showed mixed associations with competency, suggesting that these factors may not be the best criteria for selecting CHWs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training and experience outperform literacy and formal education as predictors of community health worker knowledge and performance, results from Rongo sub-county, Kenya. Rogers, A., Goore, LL., Wamae, J., et al.[2023]

Community health care workers in northern Karnataka, India, have limited understanding of the causes of pre-eclampsia and eclampsia, often attributing hypertension to psychological factors rather than medical ones.

Despite some misconceptions, these workers possess basic knowledge of managing hypertensive disorders in pregnancy, such as recommending rest and dietary changes, but require further training to effectively administer treatments like magnesium sulfate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health worker knowledge and management of pre-eclampsia in rural Karnataka State, India. Ramadurg, U., Vidler, M., Charanthimath, U., et al.[2018]

Community health worker (CHW) interventions, particularly those involving home visits and women's groups, can improve equitable access to maternal and newborn health services in low-income and middle-income countries, as shown in a review of 22 studies.

While some CHW interventions have successfully reduced health inequities, others have not, indicating that the effectiveness of these programs can vary based on the type of intervention and the support provided to CHWs in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of community health worker interventions on socioeconomic inequities in maternal and newborn health in low-income and middle-income countries: a mixed-methods systematic review. Blanchard, AK., Prost, A., Houweling, TAJ.[2022]

Community health workers (CHWs) foster trust-based relationships with perinatal women, which significantly enhance their prenatal care experience and health outcomes, as reported by 39 clients in focus groups and interviews.

These relationships provide essential emotional, informational, and instrumental support, leading to improved engagement with healthcare, better health behaviors, and reduced stress, highlighting the importance of trust-building in community health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Features and Impact of Trust-Based Relationships Between Community Health Workers and Low-Resource Perinatal Women with Chronic Health Conditions. Boyd, LM., Mehra, R., Thomas, J., et al.[2021]

The PIERS on the Move (POM) mobile health application was found to be easy to use and well-received by community health workers (CHWs) in rural India, enhancing their interactions with women and families, even among those with limited smartphone experience.

While POM did not significantly increase CHWs' knowledge or self-efficacy regarding pre-eclampsia care, it effectively strengthened their roles as essential members of the antenatal healthcare system, highlighting the potential of mHealth technologies to improve healthcare access in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Worker Evaluation of Implementing an mHealth Application to Support Maternal Health Care in Rural India. Charanthimath, U., Katageri, G., Kinshella, MW., et al.[2021]

Community health workers in Mozambique can effectively screen for pre-eclampsia and eclampsia, indicating that task-sharing initial care at the community level is feasible and acceptable.

However, significant barriers exist in healthcare facilities, such as lack of necessary equipment and surgical capacity, which could hinder the management of obstetric emergencies and the referral process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of task-sharing with community health workers for the identification, emergency management and referral of women with pre-eclampsia, in Mozambique. Sevene, E., Boene, H., Vidler, M., et al.[2021]

Community health workers in Nigeria demonstrated a good understanding of pre-eclampsia, including its symptoms and risk factors, and were capable of initiating care and referrals for affected women.

Despite their knowledge, some community health workers felt limited in their ability to manage pre-eclampsia due to restrictive guidelines, highlighting the need for regular training and clearer protocols to enhance maternal health care in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers' knowledge and practice in relation to pre-eclampsia in Ogun State, Nigeria: an essential bridge to maternal survival. Sotunsa, JO., Vidler, M., Akeju, DO., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212420925006557

A content analysis of heat health action plans This study analyses the content of HHAPs to assess the extent to which they recognise pregnant women as a heat-vulnerable population, identify ...

2. nature.com nature.com/articles/s41591-024-03395-8

A systematic review and meta-analysis of heat exposure ... Hypertensive disorders of pregnancy, such as pre-eclampsia and gestational hypertension, were linked with heat exposure in 21 of the 28 studies.

3. reporter.nih.gov reporter.nih.gov/search/xRpg907A_E6siZccOeYOJA/project-details/11138448

Effects of Heat Exposure on Maternal and Pregnancy Health This study addresses critical gaps in understanding the daily heat exposure of urban residents, with a focus on pregnant women. Previous research has linked ...

4. researchgate.net researchgate.net/publication/394856670_Blending_insights_and_evidence_Co-creating_a_community_health_worker_intervention_for_postpartum_patients_with_preeclampsia

Co‐creating a community health worker intervention for ... Using human‐centered design, we engaged in a workshop with people with lived experience of preeclampsia and other adverse cardiovascular pregnancy outcomes, ...

5. thelancet.com thelancet.com/journals/lanplh/article/PIIS2542-5196(24)00113-X/fulltext

Mobilising and evaluating existing heat adaptation ... Empirical research indicates that even brief periods of extreme heat exposure are associated with adverse outcomes related to pregnancy, such as pre-eclampsia, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10298495/

A Comprehensive Review on Hot Ambient Temperature and ... We found a definite association between heat stress and APOs such as miscarriages, premature birth, stillbirth, low birthweight, and congenital abnormalities.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1871519225000654

Pregnancy and extreme heat events: A rapid review of ... Finally, this review found no evaluations of the effectiveness of interventions aimed at reducing the risks of EHE exposures to pregnant people and fetuses, ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jmwh.13502

The Impact of Extreme Heat Exposure on Pregnant People ... A meta-analysis across multiple climate and development contexts also noted an increased risk of developing preeclampsia in pregnancies with a ...

9. researchgate.net researchgate.net/publication/344342362_Community-based_maternal_health_workers'_perspectives_on_heat_risk_and_safety_a_pilot_qualitative_study

Community-based maternal health workers' perspectives ... In this study the authors examined how maternal health workers (MHWs) perceive the health risks of extreme heat exposure to pregnant women and fetuses.