H.E.A.R. for Postpartum Complications

(HEAR4Mamas Trial)

Overseen By Ellen H Gomez, MA

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Relocation, Medicaid discontinuation, Language, Incarceration, Institutionalization, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

2894 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person vs. via text/phone to improve early detection of and timely care for complications during the first six weeks postpartum for women experiencing significant health disparities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Eligibility Criteria

This trial is for postpartum women aged 18-45 who have recently given birth and are admitted to the Roper St. Francis HealthCare Postpartum Unit. Participants must be within approximately one week of delivering a live birth and insured by Medicaid.

Inclusion Criteria

OB provider working at a delivery hospital in SC and directly involved in the care of postpartum women

I gave birth to a baby at 26 weeks or later about 2 weeks ago.

I am a new mother covered by Medicaid.

Exclusion Criteria

Postpartum woman planning to relocate outside of SC anytime during the postpartum year

Postpartum woman incarcerated/pending incarceration during peripartum period

Postpartum woman currently institutionalized

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AIM safety bundles either in-person or via text/phone to monitor postpartum complications

6 weeks

Regular virtual check-ins via text/phone

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Surveys at 3, 6, and 12 months postpartum

Treatment Details

Interventions

• H.E.A.R. for Mamas

Trial Overview The study compares two methods of delivering AIM safety bundles designed to detect and manage postpartum complications: traditional in-person delivery versus text/phone communication during the first six weeks after childbirth.

Participant Groups

Group I: Usual Care plus H.E.A.R. for Mamas Experimental Treatment 1 Intervention

H.E.A.R. for Mamas is designed to provide the AIM (Alliance for Innovation on Maternal Health) Postpartum Discharge Transition education systematically and to frequently monitor women for signs and symptoms of postpartum complications using simple, patient-centered technology (text/phone).

Group II: Usual Care Active Control 1 Intervention

AIM (AIM Alliance for Innovation on Maternal Health) safety bundles delivered in-person

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+