Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT06273436

Conditions

Postpartum Complication

Eligibility Criteria

Sex: Female

Age: 16 - 49

Healthy Volunteers: Not accepted

Interventions

H.E.A.R. for Mamas

Study Details

Brief summary:

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.

Conditions

Postpartum Complication

Study ID

NCT06273436

Start date

May 28, 2024

Status verified date

Jul, 2026

Completion date

Mar 30, 2030

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 49

Healthy Volunteers: Not accepted

Inclusion Criteria for Postpartum Women

  • Postpartum woman within approximately 2 weeks of delivering a baby of gestational age ≥ 26 weeks in South Carolina.
  • Aged 16-49 years old.
  • Insured by Medicaid.

Exclusion Criteria for Postpartum Women

  • Plans to relocate outside of SC anytime during the postpartum year.
  • Plans to discontinue Medicaid health insurance during the postpartum year.
  • Speaks a language other than English or Spanish.
  • Incarcerated/pending incarceration during peripartum period.
  • Currently institutionalized.
  • Enrolled in current MUSC study funded by PCORI (#Pro00123833)
  • Does not have and/or does not wish to use their personal cell phone for the study.

Inclusion Criteria for Obstetric Providers and Hospital Administrators

\- OB provider working at a delivery hospital in SC and directly involved in the care of postpartum women; or hospital administrator working in a delivery hospital in SC and job responsibilities relate to the postpartum unit.

Exclusion Criteria for Obstetric Providers and Hospital Administrators

  • Less than 1 month of HEAR 4 Mamas experience if involved in the hospital where participants are recruited from.
  • Unable or unwilling to commit to completing surveys or an interview.
  • Speaking a language other than English.

Study Design

Enrollment

2894 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Usual Care

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

experimental: Usual Care plus H.E.A.R. for Mamas

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).

Interventions

H.E.A.R. for Mamas

H.E.A.R. for Mamas is a patient and provider informed, multicomponent intervention that uses simple text/phone-based screenings to systematically and frequently monitor women for postpartum complications, chronic conditions and SDoH (Social Determinants of Health) and provides patients with immediate feedback and recommendations based on their screenings.

Primary outcome measure

  • Emergency Department (ED) visits within six weeks postpartum [ Time Frame: Within six weeks following the delivery ]

Central Contacts and Locations

Central contacts

Constance Guille, MD

843-792-6489guille@musc.edu

Edie Douglas

8439985635douglaed@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • AIM (Alliance for Innovation on Maternal Health) safety bundles
  • Randomized Controlled Trial (RCT)
  • Emergency Department (ED) visits
  • Shared Decision Making (SDM)
  • Patient-Reported Outcomes (PROs)
  • Patient Stakeholder Group (PSG)
  • Study Advisory Committee (SAC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-22.