Integrated care for mothers and infants to improve postpartum health
The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems
This study is testing a new care program for new moms and their babies to see if it can help reduce postpartum depression, anxiety, and health issues in the year after childbirth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 384 (estimated) |
| Sex | Female |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06277661 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant women with a diagnosis or history of postpartum depression, anxiety, or cardiometabolic conditions.
Not a fit: Patients without a history of the specified conditions or those not currently pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental and physical health outcomes for postpartum women and their infants.
How similar studies have performed: Other studies have shown promise in integrated care approaches for postpartum health, suggesting potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.