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NCT Number: NCT07006324

Mississippi Delta Community Care Home Visits Program

Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities.

These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mississippi State Department of Health, Jackson, Mississippi, United States

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About this study

Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial/ethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This research center will conduct two multi-layered research projects. Research Project 1 will determine the effectiveness of an evidenced-based community health worker home visiting program grounded in extensive patient and community participation. Research Project 2 will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities. These research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Identified as high risk pregnancy
  • Postpartum mothers/parents 18-45 years
  • Resident of the one of 5 target counties (Washington, Bolivar, Scott, Humphreys, and Carroll)

Exclusion criteria

  • not identified as high risk pregnancy
  • 18 years of age postpartum
  • cesarean birth
  • non-resident of the 5 target counties

Treatment and study plan

The PEN-3 Intervention Model

Behavioral

The PEN-3 Model is a sociocultural model for planning and assessing participant behavior within the context a cultural phenomenon. It will be used to assess intervention impact on patient-clinical linkages in the Mississippi Delta. 3-4 home visits with appropriate interventions through a referral and support process.

Primary outcomes

  1. Number of ED visits in the first 6 weeks postpartum care of the home visits intervention

    Time frame: Up to 1 year postpartum

    Difference between the number of ED visits in the first 6 weeks postpartum of the home visits in the intervention vs. non-intervention groups

Secondary outcomes

  1. Severe maternal morbidity rates in target counties compared to non-target counties

    Time frame: Up to 1 year postpartum

    The difference in de novo severe maternal morbidity rates.

Study contacts

Contact information is provided by the study sponsor or research team.

Girmay Berhie, PhD, MSW

CONTACT

[email protected]

304-360-5050

Mary Shaw, PhD

CONTACT

[email protected]

601-979-3103

Sponsors and collaborators

Lead sponsor

Jackson State University

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • Mississippi State Department of Health
  • University of Mississippi Medical Center

Registry information

Official study title

Community Care Home Visiting Program to Reduce Maternal Health Inequities

Acronym: Time4Mom

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jun 5, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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