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The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems
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.
Using this data, the investigators will address the following Specific Aims: Specific Aim 1: To evaluate the effectiveness of MOMI PODS versus EUC in mitigating cardiometabolic and mental health risk across the PP year. Hypotheses: MOMI PODS (vs. EUC) recipients will show better cardiometabolic and mental health (Primary Outcomes: higher Life's Essential 8 scores, fewer depressive and anxiety symptoms, Secondary Outcomes: fewer emergency visits and hospital readmissions). Specific Aim 2: To identify the biopsychosocial mechanisms through which MOMI PODS affects PP cardiometabolic and mental health at the individual patient level. Hypotheses: MOMI PODS (vs. EUC) recipients will report better patient-provider relationships and less psychosocial stress and show better stress-responsive endocrine and immune profiles, which will be critical drivers of cardiometabolic and mental health. Specific Aim 3: To determine if MOMI PODS promosed longitudinal delivery of evidence-based PP care and identify strategies to improve implementation and service outcomes. Hypotheses: MOMI PODS (vs. EUC) recipients will receive clinical and supportive care that is more adherent to evidence-based guidelines. Objective: Identify strategies to improve implementation and service outcomes by evaluating fidelity and timeliness of clinical and supportive care across MOMI PODS sites.
Age
All ages
Sex
FEMALE
Healthy Volunteers
No
The Ohio State University
Columbus, Ohio, United States
Start Date
June 27, 2024
Primary Completion Date
November 1, 2027
Completion Date
March 1, 2028
Last Updated
February 13, 2026
384
ESTIMATED participants
MOMI PODS
BEHAVIORAL
Enhanced Usual Care (EUC)
BEHAVIORAL
Lead Sponsor
Ohio State University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06055036