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Behavioral Intervention

MOMI PODS for Postpartum Health

N/A
Recruiting
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Index pregnancy affected by type 1 diabetes mellitus
Index pregnancy affected by type 2 diabetes mellitus
Must not have
Maternal age <18 without a parent or legal guardian present at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (t1) to 12 months postpartum (t3)
Awards & highlights

Summary

This trial aims to reduce the risk of pregnancy-related mortality by providing better care for mothers and infants after childbirth. They will test a new system called MOMI PODS against enhanced usual care (MOM

Who is the study for?
The MOMI Study is for new mothers and their infants, specifically those affected by conditions like metabolic syndrome or postpartum depression/anxiety. Participants are enrolled on the first day after giving birth and will be followed up with at 6 months and 1 year postpartum.
What is being tested?
This study tests a care system called MOMI PODS against Enhanced Usual Care (EUC), aiming to improve health outcomes for mother-infant pairs. It's a randomized controlled trial where participants are randomly assigned to one of the two groups.
What are the potential side effects?
Since this trial involves clinical and supportive care rather than medication, side effects may not be as common as in drug trials. However, any potential discomfort from participation procedures will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My current pregnancy is affected by type 1 diabetes.
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I have type 2 diabetes during my current pregnancy.
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My current pregnancy is affected by depression or anxiety.
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My current pregnancy is affected by chronic high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 and do not have a parent or guardian with me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (t1) to 12 months postpartum (t3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (t1) to 12 months postpartum (t3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Change in Life's Essential 8 (LE8) Composite Score
Change in Patient Health Questionnaire-9 (PHQ-9) Score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
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.
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
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.

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Who is running the clinical trial?

Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,381 Total Patients Enrolled
~256 spots leftby Jun 2027
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