The Mom and Infant Outcomes (MOMI) Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorOhio State University

About this trial

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 criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

  • MOMI PODS
  • Enhanced Usual Care (EUC)

Treatment groups

384 Participants
are divided into 2 treatment groups

Sponsors and collaborators