Clinical trial NCT05339867: Prevent Maternal Mortality Using Mobile Technology
Official title: Prevent Maternal Mortality Using Mobile Technology (PM3)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Partum
Keywords: Postpartum Black mothers
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Number of completion of postpartum healthcare visit ( Healthcare Resource utilization)
timeFrame: At weeks 4 to 6 postpartum
Secondary outcomes:
measure: Changes in Current Life Situation
timeFrame: Baseline, month 3, month 6 and month 12
measure: Changes in Women Sexual Health History
timeFrame: Baseline, month 3, month 6 and month 12
measure: Changes in Blood pressure
timeFrame: Baseline, month 3, month 6 and month 12
measure: Changes in Health related quality of life questionnaires (HRQoL)
timeFrame: Baseline, month 3, month 6 and month 12
measure: Changes in Hair cortisol levels
timeFrame: Baseline and 3 months
measure: Edinburg Postpartum Depression Scale
timeFrame: Baseline, month 3, month 6 and month 12
measure: Changes in Promis-GSF
timeFrame: Baseline, month 3, month 6 and month 12
measure: Discrimination & Stigma Scale
timeFrame: Baseline, month 3, month 6 and month 12
measure: System Usability Scale
timeFrame: Baseline, month 3, month 6 and month 12
measure: Race-related stress (Index of Race-Related Stress-Brief)(IRRS-B)
timeFrame: Baseline, month 3, month 6 and month 12
measure: Changes in Sleep (Karolinska Sleep Questionnaire - KSS)
timeFrame: Baseline, month 3, month 6 and month 12
measure: Medical Mistrust Index (MMI)
timeFrame: Baseline, month 3, month 6 and month 12
measure: Stressful Events Questionnaire
timeFrame: Baseline, month 3, month 6 and month 12
measure: Adverse Childhood Experiences (ACEs) questionnaire
timeFrame: Baseline, month 3, month 6 and month 12
measure: General Perceived Self-Efficacy Scale
timeFrame: Baseline, month 3, month 6 and month 12
measure: Social Support- The Medical Outcomes Study
timeFrame: Baseline, month 3, month 6 and month 12
measure: The Neighborhood Questionnaire
timeFrame: Baseline, month 3, month 6 and month 12
measure: Appraisal of self-care agency Scale-Revised (ASAS-R)
timeFrame: Baseline, month 3, month 6 and month 12
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Atlanta
country: United States
facility: Emory University, Nell Hodgson Woodruff School of Nursing
state: Georgia
Study officials:
affiliation: Assistant Professor
name: Natalie Hernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: