RecruitingNot ApplicableNCT06277661

The Mom and Infant Outcomes (MOMI) Study

The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems


Sponsor

Ohio State University

Enrollment

384 participants

Start Date

Jun 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study, called MOMI, is testing a coordinated care program (PODS) that helps pregnant women with high-risk conditions — such as high blood pressure, diabetes, or depression/anxiety — stay connected to their doctors and receive better support after delivery. **You may be eligible if...** - You are pregnant - You have one or more of these conditions: chronic or gestational high blood pressure, preeclampsia, eclampsia, HELLP syndrome, Type 1 or 2 diabetes, gestational diabetes, or a depression or anxiety disorder - You are carrying a single baby - You have private or government health insurance **You may NOT be eligible if...** - You are already enrolled in a MOMI PODS program - You have a seizure disorder - Your baby has a serious condition that would significantly delay or prevent routine pediatric outpatient care in the first year of life (e.g., major heart defects, severe birth defects) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMOMI PODS

MOMI PODS is an innovative, dyadic model of PP primary care. Informed by the Chronic Care Model (CCM) and extensive stakeholder engagement, the MOMI PODS suite of services addresses four primary domains, with a focus on preventing PRM and eliminating SES, racial, and ethnic disparities in PRM. First, MOMI PODS is a dyadic model of care, with mothers and infants cared for in tandem throughout the PP year, and beyond. Second, MOMI PODS was strategically designed to facilitate a coordinated obstetric to PP primary care transition. Third, MOMI PODS is delivered in a way that promotes tailored, evidence-based care informed by the obstetric history. Fourth, MOMI PODS systematically integrates clinical and supportive care to concurrently address clinical and psychosocial needs, with MOMI PODS engagement extending beyond the typical referral process to facilitate direct access to needed resources and empower patients.

BEHAVIORALEnhanced Usual Care (EUC)

Usual care will be enhanced in by implementing an enhanced PP care handoff as an adaptation of typical institutional discharge procedures. Specifically, under current processes, birthing parents are asked to provide the name of their infant's pediatrician during the L\&D admission, must provide the name of their infant's pediatrician prior to discharge, and are assisted with identifying a pediatrician throughout this process as needed. Alternatively, under current processes, mothers are reminded to seek PP care but not required to identify the location of care or assisted with doing so. As a component of EUC, we'll provide participants with information about our 7 EUC sites and actively assist with identifying their preferred location of care and scheduling PP care. Our research team will also engage with EUC recipients throughout the study period to encourage engagement and study retention through small care packages and hand-written notes, as well as data collection.


Locations(1)

The Ohio State University

Columbus, Ohio, United States

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NCT06277661


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