An interventional study of H.E.A.R. for Mamas in Postpartum Complication, sponsored by Medical University of South Carolina. Recruiting at 1 site in United States. Open to female participants aged 16 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Prevention
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.
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.
Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria for Postpartum Women
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
AIM (AIM Alliance for Innovation on Maternal Health) safety bundles delivered in-person
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).
Other: 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.
Emergency Department (ED) visits within six weeks postpartum
Percent of postpartum women with an ED visit that occurs within six weeks following delivery
Time frame: Within six weeks following the delivery
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.
Time frame: time of study enrollment (baseline=0), and 3, 6, and 12 months postpartum
Social Determinants of Health (SDoH), Patient Activation, Shared Decision Making
SDoH will be measured by the Accountable Health Communities-Health-Related Social Needs (HRSN) and includes assessment of economic instability, low social support, food scarcity etc.
Time frame: HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum
Patient Activation
Patient activation will be measured by the Patient Activation Measure (PAM-10).
Time frame: HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum
Shared Decision Making
Perception of the shared decision-making process will be measured by Shared Decision-Making Questionnaire (SDM-Q-9).
Time frame: HRSN, PAM-10, and SDM-Q-9 will be measured at study enrollment (baseline=0), 3, 6, and 12 months postpartum
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