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The Mom and Infant Outcomes (MOMI) Study
NCT06277661 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Enhanced Usual Care (EUC)
- BEHAVIORAL MOMI PODS
Study Locations (1)
Ohio
- The Ohio State University — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2024-06-27 |
| Est. Completion | 2028-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06277661
The ClinicalTrials.gov registry entry for NCT06277661 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 640 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Postpartum Depression appearing as the primary indexed condition, and to 2 interventions — of which Enhanced Usual Care (EUC) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06277661 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06277661 about?
NCT06277661 is a clinical study titled "The Mom and Infant Outcomes (MOMI) Study". 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...
What is the current status of trial NCT06277661?
This trial is currently recruiting. It is a NA study. The enrollment target is 384 participants. The study started on 2024-06-27. Estimated completion is 2028-03-01.
What conditions does trial NCT06277661 study?
This clinical trial studies the following conditions: Postpartum Depression, Cardiometabolic Syndrome, Postpartum Anxiety. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06277661?
The interventions under investigation include: Enhanced Usual Care (EUC) (BEHAVIORAL), MOMI PODS (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06277661?
This trial is sponsored by Ohio State University, which has 640 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06277661 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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