Clinical trial NCT06277661: The Mom and Infant Outcomes (MOMI) Study
Official title: The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Postpartum Anxiety
Cardiometabolic Syndrome
Keywords: Postpartum
Mental Health
Cardiometabolic Health
Maternal-Infant Health
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 384
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. 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 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.

Detailed description: Using this data, the investigators will address the following Specific Aims:

Specific Aim 1: To evaluate the effectiveness of MOMI PODS versus EUC in mitigating cardiometabolic and mental health risk across the PP year. Hypotheses: MOMI PODS (vs. EUC) recipients will show better cardiometabolic and mental health (Primary Outcomes: higher Life's Essential 8 scores, fewer depressive and anxiety symptoms, Secondary Outcomes: fewer emergency visits and hospital readmissions).

Specific Aim 2: To identify the biopsychosocial mechanisms through which MOMI PODS affects PP cardiometabolic and mental health at the individual patient level. Hypotheses: MOMI PODS (vs. EUC) recipients will report better patient-provider relationships and less psychosocial stress and show better stress-responsive endocrine and immune profiles, which will be critical drivers of cardiometabolic and mental health.

Specific Aim 3: To determine if MOMI PODS reduces socioeconomic (SES), racial, and ethnic disparities in evidence-based PP care delivery and identify strategies to improve implementation and service outcomes. Hypotheses: MOMI PODS (vs. EUC) recipients will receive clinical and supportive care that is more adherent to evidence-based guidelines, which will reduce SES, racial, and ethnic disparities in evidence-based care. Objective: Identify strategies to improve implementation and service outcomes by evaluating fidelity, timeliness, and equity of clinical and supportive care across MOMI PODS sites.

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).

Primary outcomes:
measure: Change in Life's Essential 8 (LE8) Composite Score
timeFrame: Baseline (T1) to 6 months postpartum (T2)
measure: Change in Life's Essential 8 (LE8) Composite Score
timeFrame: 6 months postpartum (T2) to 12 months postpartum (T3)
measure: Change in Life's Essential 8 (LE8) Composite Score
timeFrame: Baseline (T1) to 12 months postpartum (T3)
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Baseline (T1) to 6 months postpartum (T2)
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: 6 months postpartum (T2) to 12 months postpartum (T3)
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Baseline (T1) to 12 months postpartum (T3)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score
timeFrame: Baseline (T1) to 6 months postpartum (T2)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score
timeFrame: 6 months postpartum (T2) to 12 months postpartum (T3)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Score
timeFrame: Baseline (T1) to 12 months postpartum (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: