Integrated care for mothers and infants to improve postpartum health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) compared to enhanced usual care (EUC) in reducing postpartum depression, anxiety, and cardiometabolic syndrome among mother-infant dyads. Participants will be enrolled on the first day postpartum and will receive integrated clinical and supportive care over the following year. The study aims to assess improvements in mental health and cardiometabolic profiles, as well as to identify mechanisms that contribute to these outcomes. Additionally, it seeks to address disparities in postpartum care delivery based on socioeconomic, racial, and ethnic factors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

To be eligible for the MOMI PODS RCT, individuals will be required to be pregnant, with a current diagnosis or history of one or more of the following reflected in the medical record or by self-report - chronic hypertension (with or without super-imposed preeclampsia); gestational hypertension; preeclampsia; eclampsia; hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome; type 1 diabetes mellitus; type 2 diabetes mellitus; gestational diabetes mellitus (GDM); a depressive disorder (e.g., major depressive disorder, persistent depressive disorder) or anxiety disorder (e.g., generalized anxiety disorder, panic disorder).43-48 Inclusion criteria will also include a singleton pregnancy and medical record documentation or self-report of private or government-sponsored health insurance at the time of enrollment.

Exclusion Criteria:

Exclusion criteria will include the presence of a pre-existing, community driven MOMI PODS referral and enrollment into the program, maternal history of a seizure disorder, medical record documentation or self-report of a major complication of the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to anencephaly, myelomeningocele, esophageal atresia, gastroschisis, hypoplastic left heart syndrome, transposition of the great arteries, or tetralogy of Fallot. Exclusion criteria will also include the presence of a major genetic disorder among the infant that would be expected to preclude them from receiving or significantly delay their ability to receive outpatient pediatric care during the first year of life. Examples include but are not limited to trisomy 13, or trisomy 18 (trisomy 21 is not an exclusion criteria).

Where it's running

• The Ohio State University
  Columbus, Ohio, United States Recruiting

Study contacts

• Study coordinator: Shannon L. Gillespie, PhD, RN
• Email: gillespie.175@osu.edu
• Phone: 6142924589

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.