Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-30 @ 3:00 AM
Study NCT ID:
NCT06277661
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Mom and Infant Outcomes (MOMI) Study
Sponsor:
Ohio State University
Organization:
Study Overview
Official Title:
The Mom and Infant Outcomes (MOMI) Study: A Trial of Perinatal Outpatient Delivery Systems
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: