Actively Recruiting
The Mom and Infant Outcomes (MOMI) Study
Led by Ohio State University · Updated on 2026-05-14
384
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Mom and Infant Outcomes (MOMI) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant individuals with a current diagnosis or history of chronic hypertension, gestational hypertension, preeclampsia, eclampsia, HELLP syndrome, type 1 or type 2 diabetes, gestational diabetes, depressive disorder, or anxiety disorder
- Singleton pregnancy
- Medical record or self-report of private or government-sponsored health insurance at enrollment
You will not qualify if you...
- Enrollment in a community-driven MOMI PODS referral program
- Maternal history of a seizure disorder
- Infant has a major complication expected to prevent or significantly delay outpatient pediatric care during the first year of life, including but not limited to anencephaly, myelomeningocele, esophageal atresia, gastroschisis, hypoplastic left heart syndrome, transposition of the great arteries, or tetralogy of Fallot
- Infant has a major genetic disorder expected to prevent or significantly delay outpatient pediatric care during the first year of life, including but not limited to trisomy 13 or trisomy 18 (trisomy 21 is not an exclusion)
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
S
Shannon L. Gillespie, PhD, RN
CONTACT
S
Sandra Solove, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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