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The Mom and Infant Outcomes (MOMI) Study

StatusRecruiting
PhaseNot applicable
Started2024-06-27
View on ClinicalTrials.gov ↗
The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk for all by increasing patient engagement with evidence-based cilnical and supportive care, thus improving biopsychosocial profiles that drive clinical risk. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of up to 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants during late pregnancy and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.

Amendment history 1 change detected by DataLookout

2026-05-15
notable
Primary completion pushed: 2027-11-01 → 2027-12-31
Trial Details
NCT Number NCT06277661
Lead Sponsor Ohio State University
Conditions Postpartum Depression, Postpartum Anxiety, Cardiometabolic Syndrome
Enrollment 384 participants
Start Date 2024-06-27
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-14