Recruiting

Maternal Health Equity

Sponsor:

Jackson State University

Code:

NCT07006324

Conditions

Maternal Behavior

Postpartum Mood Disturbance

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

The PEN-3 Intervention Model

Study Details

Brief summary:

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.

Conditions

Maternal Behavior

Postpartum Mood Disturbance

Study ID

NCT07006324

Start date

Aug 1, 2025

Status verified date

Aug, 2025

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: PEN-3 Assessment Model

Application of a sociocultural model to assess patient-clinical linkages that support positive maternal health outcomes

Interventions

The PEN-3 Intervention Model

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 outcome measure

  • Number of ED visits in the first 6 weeks postpartum care of the home visits intervention [ Time Frame: Up to 1 year postpartum ]

Central Contacts and Locations

Central contacts

Locations

Mississippi State Department of Health

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

James Tucker, MD

jtucker1@umc.edu

More Information

Sponsor

Jackson State University

Last update posted

Sep 2, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jackson State University on 2025-09-02.