Healing, Equity, Advocacy and Respect for Mamas

Not Applicable

Recruiting

• Conditions: Postpartum Complication
• Interventions: Other: H.E.A.R. for Mamas

• Registration Number: NCT06273436
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 3 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a nurse advocate will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Study Timeline

• Study First Submitted: 2024-01-27
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-22
• Study Start: 2024-05-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2028-11-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2894

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care plus H.E.A.R. for Mamas	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).

Primary Outcome Measures

Name	Time	Method
Emergency Department (ED) visits within six weeks postpartum	Within six weeks following the delivery	Percent of postpartum women with an ED visit that occurs within six weeks following delivery

Secondary Outcome Measures

Name	Time	Method
Patient Reported Outcomes (PROs)	time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum	Secondary outcomes will include PROs which will be measured at the time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States