Postpartum ComplicationHEAR4MamasNCT06273436
Healing, Equity, Advocacy and Respect for Mamas
A study testing H.E.A.R. for Mamas in people with Postpartum Complication, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women only
- Conditions the study is for
- Postpartum Complication
- What is being tested?
- H.E.A.R. for Mamas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,894 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2024to 30 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Constance Guille, MD
About this study
Official title: Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits
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.
Read the 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.
- Conditions
- Postpartum Complication
- Being tested
- H.E.A.R. for Mamas
- 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)
- Medical subject headings
- Episodic Ataxia, Type 1, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.E.A.R. for MamasOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | AIM (AIM Alliance for Innovation on Maternal Health) safety bundles delivered in-person |
| Usual Care plus H.E.A.R. for Mamas | Experimental | 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). Receives: Other: H.E.A.R. for Mamas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergency Department (ED) visits within six weeks postpartum
Percent of postpartum women with an ED visit that occurs within six weeks following delivery
Measured: Within six weeks following the delivery
Secondary outcomes (1)
Patient Reported Outcomes (PROs)
Secondary outcomes will include PROs which will be measured at the time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum.
Measured: time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start28 May 2024
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum ComplicationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,894 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Constance Guille, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273436
- Sponsor's protocol ID
- Pro00130902
- Acronym
- HEAR4Mamas
- Status last verified
- Jul 2026
- First submitted
- 27 Jan 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits
- ClinicalTrials.gov ID
- NCT06273436
- Acronym / sponsor ID
- HEAR4Mamas / Pro00130902
- Conditions
- Postpartum Complication
- 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)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,894 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 28 May 2024 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –AIM (AIM Alliance for Innovation on Maternal Health) safety bundles delivered in-person |
| Usual Care plus H.E.A.R. for Mamas | Experimental | Other: H.E.A.R. for MamasH.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). |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H.E.A.R. for MamasH.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. | Other | Usual Care plus H.E.A.R. for Mamas |
Primary outcome
Emergency Department (ED) visits within six weeks postpartum
Time frame: Within six weeks following the delivery
Percent of postpartum women with an ED visit that occurs within six weeks following delivery
1 secondary outcome
Patient Reported Outcomes (PROs)
Time frame: time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H.E.A.R. for Mamas in people with Postpartum Complication, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Constance Guille, MD (843-792-6489, guille@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergency Department (ED) visits within six weeks postpartum (time frame: Within six weeks following the delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.