Prevent Maternal Mortality Using Mobile Technology

NCT ID: NCT05339867

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2023-03-31

Brief Summary

Black women who reside in a rural area are at highest risk for maternal morbidity and mortality due to a combination of social and structural causes. The postpartum period is the most critical yet most neglected phase for preventing suboptimal or fatal maternal health outcomes. The goal of this project is to use a mobile app to provide personalized support and improve the lives of women during the early postpartum period. The information the study team gathers will help educate women and all who support them about the need to seek postpartum care and the impact postpartum care can have on pregnancy-related complications. Participation in this research requires taking part in a focus group discussion which will allow participants to share or the person that supports the participant's story and experience with postpartum complications and willingness to use and desired features of a postpartum mobile app.

Detailed Description

Black women in Georgia have the highest risk for adverse maternal outcomes, with a staggering 66.6 deaths per 100,000 live births, compared to 18.1 for Hispanic women and 43.2 for white women. In rural Georgia, these statistics are more profound, with Black women experiencing 126.7 deaths per 100,000 live births compared to 78.3 deaths for White women. These disparities have existed for centuries and have also widened significantly over the last several decades.

The proposed research aims to increase the effectiveness of postpartum discharge education and improve rural Black women's compliance with postpartum care recommendations by developing and testing a culturally-informed "mhealth intervention" entitled Prevent Maternal Mortality using Mobile technology (PM3).

Conditions

Post-Partum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mothers following Standard of Care

Participants randomized to this group will receive standard of Care for Postpartum. The standard of care control condition will be what women would typically get at hospital discharge (typically an Electronic Medical Record (EMR) generated document; a non-standardized, generalized brief review of how to care for self and the baby).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mother Using PM3 Intervention

Participants in this group will be using the PM3 intervention. PM3 is a maternal mortality prevention and optimal reproductive health promotion mobile app created based on formative work with Black women to ultimately increase postpartum comorbidity self-management, promote timely provider notification of postpartum-related complications, and ensure access to social support and community resources.

Group Type: EXPERIMENTAL

Prevent Maternal Mortality using Mobile technology (PM3)

Intervention Type: BEHAVIORAL

PM3: The app will include:

1. integrated self-management and tailored health messaging feature

2. support center based on social support gaps which will also provide a centralized place for identifying healthcare providers and facilities

3. multimedia resource kit comprised of videos, current events, news feeds, podcasts, and support groups related to women's postpartum health and community resources

4. a feature that will update women on maternal and reproductive health policies that impact women.

Interventions

Prevent Maternal Mortality using Mobile technology (PM3)

PM3: The app will include:

1. integrated self-management and tailored health messaging feature

2. support center based on social support gaps which will also provide a centralized place for identifying healthcare providers and facilities

3. multimedia resource kit comprised of videos, current events, news feeds, podcasts, and support groups related to women's postpartum health and community resources

4. a feature that will update women on maternal and reproductive health policies that impact women.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Participants self -identify as female
• Participants must self-identify as African American/Black
• Aged 18-45 years
• Can speak or read English
• Participants must be able to give consent.
• Own a smart phone
• Reside in or near Albany, LaGrange, or Waynesboro (within a 40 mile radius)
• Be in third trimester or recently had a baby (≤4 weeks postpartum)
• Can be contacted by phone or email after hospital discharge.

Exclusion Criteria

• Women will be excluded if they have known unavailability to follow-up
• An active severe mental health condition, or developmental disability precluding informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Natalie Hernandez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalie Hernandez, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Morehouse School of Medicine

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University, Nell Hodgson Woodruff School of Nursing

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rasheeta Chandler, PhD

Role: CONTACT

r.d.chandler@emory.edu

404-727-8164

Rashidat Ayantunji, MPH

Role: CONTACT

rayantu@emory.edu

Facility Contacts

Natalie Hernandez, PhD

Role: primary

nhernandez@msm.edu

404-752-1523

Rasheeta Chandler, PhD

Role: primary

r.d.chandler@emory.edu

404-727-8164

Other Identifiers

STUDY00003016

Identifier Type: -

Identifier Source: org_study_id