The Mom and Infant Outcomes (MOMI) Study

Launched by OHIO STATE UNIVERSITY · Feb 23, 2024

Keywords

ClinConnect Summary

The MOMI Study is a clinical trial designed to help mothers and their babies who are experiencing postpartum depression, anxiety, or certain health conditions related to pregnancy, such as high blood pressure or diabetes. The researchers want to see if a new program called MOMI PODS, which provides a combination of clinical care and support, can improve health outcomes for mothers and infants compared to standard care. They are looking for 384 mother-infant pairs to participate, and they will start enrolling mothers right after they give birth. Participants will receive care for up to a year and will be asked to share their health information at the beginning of the study and again at six months and one year after giving birth.

To be eligible for the study, mothers must be pregnant and have a diagnosis of conditions such as chronic hypertension, gestational diabetes, or a depressive or anxiety disorder. They also need to have health insurance. However, mothers who have certain serious health issues or complications with their baby may not be able to participate. This study aims to provide better support for mothers during the challenging postpartum period and reduce health risks for both mothers and their infants. If you or someone you know might qualify, this could be an important opportunity to receive specialized care and support.

Gender

FEMALE

Eligibility 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).