MOMI PODS for Postpartum Health

Overseen By Sandra Solove, MA

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Seizure disorder, Major infant complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 months

384 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the MOMI PODS treatment for postpartum health?

The MOMI PODS program shows promise in improving postpartum health by integrating outpatient care into pediatric structures, which increases access to healthcare and promotes better health outcomes for postpartum individuals, especially those who are publicly insured. ^{1 2 3 4 5}

What safety data exists for the MOMI PODS program for postpartum health?

The MOMI PODS program is designed to improve postpartum care by integrating it into pediatric care structures, focusing on increasing access to healthcare for postpartum individuals. While the program aims to mitigate maternal health risks, the available research does not provide specific safety data or adverse event information related to the program itself. ^{1 4 6 7 8}

How is the MOMI PODS treatment different from other postpartum health treatments?

MOMI PODS is unique because it integrates postpartum care into pediatric care structures, improving access to primary care and community resources for postpartum individuals, especially those who are publicly insured. This approach focuses on mitigating maternal health risks by providing a collaborative care model involving multiple healthcare disciplines, which is not typically seen in standard postpartum care. ^{1 9 10 11 12}

What is the purpose of this trial?

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.

Eligibility Criteria

The MOMI Study is for new mothers and their infants, specifically those affected by conditions like metabolic syndrome or postpartum depression/anxiety. Participants are enrolled on the first day after giving birth and will be followed up with at 6 months and 1 year postpartum.

Inclusion Criteria

Index pregnancy affected by gestational diabetes mellitus (GDM)

Index pregnancy affected by eclampsia

Index pregnancy affected by hemolysis, elevated liver enzymes and low platelets (HELLP) syndrome

Exclusion Criteria

Presence of a pre-existing, community driven MOMI PODS referral that has already been scheduled

Maternal history of syncope during venipuncture

Maternal history of a seizure disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive either MOMI PODS or Enhanced Usual Care (EUC) interventions, focusing on postpartum care and reducing disparities in postpartum risk.

12 months

Regular visits throughout the postpartum year

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at 6 months and 1 year postpartum.

6 months

Data collection at 6 months and 12 months postpartum

Treatment Details

Interventions

• Enhanced Usual Care (EUC)
• MOMI PODS

Trial Overview This study tests a care system called MOMI PODS against Enhanced Usual Care (EUC), aiming to improve health outcomes for mother-infant pairs. It's a randomized controlled trial where participants are randomly assigned to one of the two groups.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

MOMI PODS is an innovative, dyadic model of PP primary care. Informed by the Chronic Care Model (CCM) and extensive stakeholder engagement, the MOMI PODS suite of services addresses four primary domains, with a focus on preventing PRM and eliminating SES, racial, and ethnic disparities in PRM. First, MOMI PODS is a dyadic model of care, with mothers and infants cared for in tandem throughout the PP year, and beyond. Second, MOMI PODS was strategically designed to facilitate a coordinated obstetric to PP primary care transition. Third, MOMI PODS is delivered in a way that promotes tailored, evidence-based care informed by the obstetric history. Fourth, MOMI PODS systematically integrates clinical and supportive care to concurrently address clinical and psychosocial needs, with MOMI PODS engagement extending beyond the typical referral process to facilitate direct access to needed resources and empower patients.

Group II: Enhanced Usual Care (EUC) Active Control 1 Intervention

Usual care will be enhanced in by implementing an enhanced PP care handoff as an adaptation of typical institutional discharge procedures. Specifically, under current processes, birthing parents are asked to provide the name of their infant's pediatrician during the L\&D admission, must provide the name of their infant's pediatrician prior to discharge, and are assisted with identifying a pediatrician throughout this process as needed. Alternatively, under current processes, mothers are reminded to seek PP care but not required to identify the location of care or assisted with doing so. As a component of EUC, we'll provide participants with information about our 7 EUC sites and actively assist with identifying their preferred location of care and scheduling PP care. Our research team will also engage with EUC recipients throughout the study period to encourage engagement and study retention through small care packages and hand-written notes, as well as data collection.

MOMI PODS is already approved in United States for the following indications:

Approved in United States as MOMI PODS for:

• Postpartum care for mothers with cardiometabolic and/or mental health conditions

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

The MOMI PODS program aims to improve postpartum care by integrating it into pediatric care systems, specifically targeting publicly insured individuals to enhance access to primary care and community resources.

This innovative approach has shown promise in increasing healthcare utilization and addressing maternal morbidity risk factors, although challenges such as provider capacity and data tracking were encountered during implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a multimodal maternal infant perinatal outpatient delivery system: the MOMI PODS program. Bose Brill, S., Juckett, LA., D'Amico Gordon, R., et al.[2023]

In a study of 1,892 doula-supported adolescent births from 2000 to 2013, improved health outcomes and lower intervention rates were observed compared to national statistics for adolescent deliveries in the U.S.

The findings support the effectiveness of doula care in enhancing maternal and infant health outcomes, particularly for marginalized and medically underserved communities, highlighting its potential to reduce health inequities among young mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Care for 1,892 Doula-Supported Adolescent Births in the United States: The DONA International Data Project, 2000 to 2013. Everson, CL., Cheyney, M., Bovbjerg, ML.[2020]

20% of mothers felt unready for discharge with their infants, and having less than a high school education was a significant predictor of this feeling, indicating a potential need for additional support for less-educated mothers.

After discharge, unready mothers reported lower happiness, made more inquiries about their infants, and were more likely to place their infants in a potentially unsafe sleeping position, highlighting the importance of ensuring maternal readiness for the well-being of both mother and infant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum discharge: do varying perceptions of readiness impact health outcomes? Bernstein, HH., Spino, C., Baker, A., et al.[2019]

The postpartum period is crucial for improving maternal health, but many individuals face barriers to effective care, leading to poor health outcomes; patient navigation is a promising intervention to help overcome these obstacles.

A comprehensive training guide for postpartum patient navigators was developed, emphasizing six core elements essential for effective navigation, which can be adapted for various healthcare settings to enhance postpartum care access and quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. Yee, LM., Williams, B., Green, HM., et al.[2023]

A systematic review of 64 studies involving over 543,000 participants found that the location of postpartum care (clinic, home, or telephone) did not significantly impact maternal mental health outcomes like depression or anxiety, indicating that care delivery method may not be as critical as previously thought.

Providing contraceptive care earlier after childbirth was linked to a higher use of contraceptive implants at 6 months, suggesting that timely access to contraceptive services can improve family planning outcomes for new mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery Strategies for Postpartum Care: A Systematic Review and Meta-analysis. Saldanha, IJ., Adam, GP., Kanaan, G., et al.[2023]

The MOREOB program, aimed at improving obstetrical safety in Ontario hospitals, did not lead to a statistically significant reduction in adverse maternal and neonatal outcomes over a 12-year period involving 1,447,073 deliveries.

In fact, the study observed small but statistically significant increases in some adverse events after the program's implementation, suggesting that the program may not have achieved its intended safety improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of implementation of the MOREOB program on adverse maternal and neonatal birth outcomes in Ontario, Canada: a retrospective cohort study. Weiss, D., Fell, DB., Sprague, AE., et al.[2020]

A systematic review of 74 maternal immunization studies revealed significant variability in definitions and reporting of adverse events following immunization (AEFIs), with 240 different types of adverse events reported.

To improve the safety and efficacy of maternal immunization, there is a need for standardized AEFI definitions that are detailed and consistent, which can help reduce ambiguities and enhance data reliability in both developed and developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of adverse events following immunization during pregnancy and the newborn period. Fulton, TR., Narayanan, D., Bonhoeffer, J., et al.[2021]

The integrated group postpartum and well-child care model was successfully implemented in three clinics in Blantyre District, Malawi, with high fidelity and positive feedback from both women and healthcare workers regarding its acceptability, appropriateness, and feasibility.

The pilot sessions highlighted common health issues such as high blood pressure in women and flu-like symptoms in infants, while also providing essential services like family planning and vaccinations, indicating the model's potential to improve maternal and infant health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of implementation outcomes of an integrated group postpartum and well-child care model at clinics in Malawi. Gresh, A., Mambulasa, J., Ngutwa, N., et al.[2023]

Women using the midwifery network for postpartum care were more likely to be first-time mothers, of foreign nationality, without professional education, unemployed, and had higher rates of cesarean births, indicating that the network effectively supports those facing greater challenges in organizing care themselves.

The midwifery network not only helped vulnerable families access necessary postpartum services but also improved the work organization and resource utilization for health professionals, highlighting the mutual benefits of such networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a midwifery network to guarantee outpatient postpartum care: a mixed methods study. Grylka-Baeschlin, S., Iglesias, C., Erdin, R., et al.[2020]

The Portable Health Clinic telehealth system aims to improve maternal and infant health care in rural Bangladesh by providing regular health checkups and triaging health levels, with 295 mothers already consented for the study as of June 2022.

The study will evaluate the effectiveness of this telehealth intervention in increasing health checkup coverage and improving health outcomes for mothers and infants over a one-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Care for Mothers and Infants to Improve the Continuum of Care: Protocol for a Quasi-Experimental Study. Kikuchi, K., Islam, R., Sato, Y., et al.[2023]

The first 6 weeks postpartum, often called the fourth trimester, are crucial for the health of both mothers and newborns, yet many new mothers miss important follow-up appointments that could prevent serious health issues.

To improve postpartum care during the COVID-19 pandemic, a mobile clinic was launched in Boston, providing comprehensive care with an average of 3 visits for each mother and newborn, addressing barriers to care and promoting better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Care Mobile Units: A Collaborative Midwifery and Pediatric Response to the COVID-19 Pandemic. McGuinness, C., Mottl-Santiago, J., Nass, M., et al.[2023]

A series of initiatives over the past 5 years, led by the Association of Maternal & Child Health Programs, aim to improve postpartum care and reduce infant mortality by reimagining the postpartum visit and enhancing coordination across various health initiatives.

Key strategies proposed include creating integrated services for continuous care from preconception to postpartum, providing community and government support like paid parental leave, and ensuring mother-centered care that is culturally appropriate and flexible to meet women's needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating New Strategies to Enhance Postpartum Health and Wellness. Cornell, A., McCoy, C., Stampfel, C., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Developing a multimodal maternal infant perinatal outpatient delivery system: the MOMI PODS program. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Care for 1,892 Doula-Supported Adolescent Births in the United States: The DONA International Data Project, 2000 to 2013. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Postpartum discharge: do varying perceptions of readiness impact health outcomes? [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Bridging the postpartum gap: best practices for training of obstetrical patient navigators. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Delivery Strategies for Postpartum Care: A Systematic Review and Meta-analysis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Effect of implementation of the MOREOB program on adverse maternal and neonatal birth outcomes in Ontario, Canada: a retrospective cohort study. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of adverse events following immunization during pregnancy and the newborn period. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of implementation outcomes of an integrated group postpartum and well-child care model at clinics in Malawi. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of a midwifery network to guarantee outpatient postpartum care: a mixed methods study. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Telehealth Care for Mothers and Infants to Improve the Continuum of Care: Protocol for a Quasi-Experimental Study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Dyadic Care Mobile Units: A Collaborative Midwifery and Pediatric Response to the COVID-19 Pandemic. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Creating New Strategies to Enhance Postpartum Health and Wellness. [2022]