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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different ways to help new mothers identify and manage health issues after giving birth. It compares two methods: an in-person education program and a tech-based program called H.E.A.R. for Mamas, which uses texts or phone calls. The researchers aim to determine which method better supports women in the first six weeks after delivery, especially those facing health disparities. New mothers in South Carolina who are on Medicaid and speak English or Spanish may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to improving postpartum care for new mothers.

Will I have to stop taking my current medications?

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

What prior data suggests that the H.E.A.R. for Mamas protocol is safe for postpartum women?

Research has shown that the H.E.A.R. for Mamas program uses simple text messages and phone calls to monitor new mothers for any post-childbirth issues. Designed with input from both mothers and healthcare providers, the program aims to identify problems early so women can receive timely care.

The program reduces post-birth risks by regularly checking for warning signs, helping mothers access medical help promptly, which could save lives. Although specific data on the safety of the H.E.A.R. program is not available, technology-based regular check-ins are generally safe and well-received. This non-invasive method relies on texts or calls for communication, avoiding medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the H.E.A.R. for Mamas program because it introduces a new way to monitor and educate women after childbirth. Unlike the usual postpartum care, which typically involves in-person visits and standard safety guidelines, H.E.A.R. for Mamas uses patient-centered technology like text and phone communications. This approach allows for more frequent and systematic monitoring of postpartum complications, potentially catching issues earlier and providing timely interventions. By integrating this innovative tech-based system, the program aims to enhance postpartum care and improve outcomes for new mothers.

What evidence suggests that the H.E.A.R. for Mamas protocol is effective for postpartum complications?

Research has shown that the H.E.A.R. for Mamas program, available to participants in this trial, can identify health problems after childbirth. This program uses simple methods, such as texts and phone calls, to monitor new mothers for signs of issues. Studies have found that this type of communication helps women receive necessary care promptly. The program aims to make postpartum care more accessible and timely, which is crucial for preventing serious health problems. Overall, evidence suggests that H.E.A.R. for Mamas could effectively improve health outcomes for new mothers. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06273436

Healing, Equity, Advocacy and Respect for Mamas

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 ...

2.

muschealth.org

muschealth.org/medical-services/womens/reproductive-behavioral-health/postpartum-support-hear-4-mamas

Postpartum Support Study - H.E.A.R. 4 Mamas

The purpose of this study is to learn if a program for new moms can improve detection of complications after delivery, and help women get medical care quickly ...

3.

ctv.veeva.com

ctv.veeva.com/study/pcori-ii-improving-postpartum-maternal-outcomes

Healing, Equity, Advocacy and Respect for Mamas

The goal of the proposed research is to test the comparative effectiveness of AIM safety bundles for post-partum women delivered in-person ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10964150/

Implementation of the Hear Her Campaign - PubMed Central

A national communication campaign called “Hear Her” to raise awareness of urgent maternal warning signs during pregnancy and in the year after pregnancy.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12177326/

Opportunities and Challenges to Improve Postpartum Care

The objective was to explore their perspectives and identify challenges and opportunities in improving postpartum care in California.

6.

cdc.gov

cdc.gov/hearher/pregnant-postpartum/index.html

Pregnant and Postpartum Women | HEAR HER Campaign

If you experience an urgent maternal warning sign during or in the year after pregnancy, get medical care immediately.

7.

npqic.org

npqic.org/qi-projects/band-project.html

Postpartum Alert: A Life-Saving Maternal Safety Initiative

The Postpartum Alert Initiative focuses on reducing maternal mortality by raising awareness and enabling timely care for postpartum complications to save lives.