MOMI PODS for Postpartum Health
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University
Disqualifiers: Seizure disorder, Major infant complications, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345What 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.
14678How 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.
19101112Eligibility 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
+7 more
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
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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 Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Ohio State UniversityColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State UniversityLead Sponsor
References
Developing a multimodal maternal infant perinatal outpatient delivery system: the MOMI PODS program. [2023]Progress in maternal child health has been hampered by poor rates of outpatient follow up for postpartum individuals. Primary care after delivery can effectively detect and treat several pregnancy-related complications and comorbidities, but postpartum linkage to primary care remains low. In this manuscript, we share the experience of implementing a novel mother-infant dyad program, the Multimodal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS), to improve primary care linkage and community resource access postpartum via integration into pediatric care structures. With a focus on providing care for people who are publicly insured, we designed a program to mitigate maternal morbidity risk factors in postpartum individuals with chronic disease or pregnancy complications. We discuss the systematic process of designing, executing, and evaluating a collaborative clinical program with involvement of internal medicine/pediatric, family medicine, and obstetric clinicians via establishing stakeholders, identifying best practices, drawing from the evidence base, designing training and promotional materials, training partners and providers, and evaluating clinic enrollment. We share the challenges encountered such as in achieving sufficient provider capacity, consistent provision of care, scheduling, and data tracking, as well as mitigation strategies to overcome these barriers. Overall, MOMI PODS is an innovative approach that integrates outpatient postpartum care into traditional pediatric structures to increase access, showing significant promise to improve healthcare utilization and promote postpartum health.
Outcomes of Care for 1,892 Doula-Supported Adolescent Births in the United States: The DONA International Data Project, 2000 to 2013. [2020]This is the largest study to-date to report on outcomes of care for a national sample of doula-supported adolescent births (n = 1,892, birth years 2000 to 2013). Descriptive statistics were calculated for maternal demographics, risk profiles, labor/birth interventions and occurrences, and birth outcomes. In this national sample, childbearing adolescents and their neonates experienced improved health outcomes and lower rates of intervention relative to national statistics for adolescent deliveries in the United States. Key findings are consistent with previous studies on the effects of doula care for marginalized and medically underserved communities. Results strengthen the case for doulas as a perinatal care strategy for improving maternal and infant health outcomes and decreasing inequities among childbearing adolescents.
Postpartum discharge: do varying perceptions of readiness impact health outcomes? [2019]To assess maternal and pediatrician perceptions of mother-infant readiness for postpartum discharge and the impact of this decision making during the neonatal period.
Bridging the postpartum gap: best practices for training of obstetrical patient navigators. [2023]The postpartum period represents a critical window of opportunity to improve maternal short- and long-term health, including optimizing postpartum recovery, providing effective contraception, caring for mood disorders, managing weight, supporting lactation, initiating preventive care, and promoting cardiometabolic health. However, inadequate postpartum care, especially for individuals facing social and structural barriers, is common in the United States and contributes to suboptimal health outcomes with lasting consequences. Patient navigation is a patient-centered intervention that uses trained personnel to identify financial, cultural, logistical, and educational obstacles to effective healthcare and to mitigate these barriers to facilitate comprehensive and timely access to needed health services. Given the emerging evidence suggesting that patient navigation may be a promising method to improve health among postpartum individuals, our team developed a postpartum patient navigator training guide to be used in the Navigating New Motherhood 2 and other obstetrical navigation programs. Navigating New Motherhood 2 is a randomized trial exploring whether patient navigation by a trained, lay postpartum navigator for individuals with a low income can improve health and patient-reported outcomes during and after the postpartum period. Hiring and training patient navigators without health professional degrees are integral components of initiating a navigation program. However, patient navigator training is highly variable, and no guideline regarding key elements in such a training program exists for obstetrics specifically. Thus, this paper aimed to describe the core principles, content, and rationale for each element in a comprehensive postpartum patient navigator training program. Training should be centered around the following 6 core elements: (1) principles of patient navigation; (2) knowledge of pregnancy and postpartum care; (3) health education and health promotion principles; (4) cultural sensitivity and health equity; (5) care coordination and community resources; and (6) electronic medical record systems. These core elements can serve as a basis for the development of adaptable curricula for several institutions and contexts. In addition, we offer recommendations for the implementation of a navigator training program. A curriculum with built-in flexibility to meet community and institutional needs may promote the effective and sustainable use of patient navigation in the postpartum context.
Delivery Strategies for Postpartum Care: A Systematic Review and Meta-analysis. [2023]To systematically review the effects of postpartum health care-delivery strategies on health care utilization and maternal outcomes.
Effect of implementation of the MOREOB program on adverse maternal and neonatal birth outcomes in Ontario, Canada: a retrospective cohort study. [2020]Label="BACKGROUND" NlmCategory="BACKGROUND">In 2002, the MOREOB (Managing Obstetrical Risk Efficiently) obstetrical patient safety program was phased-in across hospitals in Ontario, Canada. The purpose of our study was to evaluate the effect of the MOREOB program on rates of adverse maternal and neonatal outcomes.
A systematic review of adverse events following immunization during pregnancy and the newborn period. [2021]In 2013, the WHO Strategic Advisory Group of Experts on Immunization (SAGE) requested WHO to develop a process and a plan to move the maternal immunization agenda forward in support of an increased alignment of data safety evidence, public health needs, and regulatory processes. A key challenge identified was the continued need for harmonization of maternal adverse event following immunization (AEFI) research and surveillance efforts within developing and developed country contexts. We conducted a systematic review as a preliminary step in the development of standardized AEFI definitions for use in maternal and neonatal clinical trials, post-licensure surveillance, and other vaccine studies. We documented the current extent and nature of variability in AEFI definitions and adverse event reporting among 74 maternal immunization studies, which reported a total of 240 different types of adverse events. Forty-nine studies provided explicit AEFI case definitions describing 35 separate types of AEFIs. We identified variability in how AEFIs were determined to be present, in how AEFI definitions were applied, and in the ways that AEFIs were reported. Definitions for key maternal/neonatal AEFIs differed on four discrete attributes: overall level of detail, physiological and temporal boundaries and cut-offs, severity strata, and standards used. Our findings suggest that investigators may proactively address these inconsistencies through comprehensive and consistent reporting of AEFI definitions and outcomes in future publications. In addition, efforts to develop standardized AEFI definitions should generate definitions of sufficient detail and consistency of language to avoid the ambiguities we identified in reviewed articles, while remaining practically applicable given the constraints of low-resource contexts such as limited diagnostic capacity and high patient throughput.
Evaluation of implementation outcomes of an integrated group postpartum and well-child care model at clinics in Malawi. [2023]Background Persistently elevated rates of maternal and infant mortality and morbidities in Malawi indicate the need for increased quality of maternal and well-child care services. The first-year postpartum sets the stage for long-term health for the childbearing parent and infant. Integrated group postpartum and well-child care may improve maternal and infant health outcomes. The purpose of this study was to examine implementation outcomes for this model of care. Methods We used mixed methods to examine implementation outcomes of integrated group postpartum and well-child care. We piloted sessions at three clinics in Blantyre District, Malawi. During each session we evaluated fidelity using a structured observation checklist. At the end of each session, we administered three surveys to health care workers and women participants, the Acceptability of Intervention Measure, the Intervention Appropriateness Measure, and the Feasibility of Intervention Measure. Focus groups were conducted to gain greater understanding of people’s experience with and evaluation of the model. Results Forty-one women with their infants participated in group sessions. Nineteen health care workers across the three clinics co-facilitated group sessions, 9 midwives and 10 health surveillance assistants. Each of the 6 sessions was tested once at each clinic for a total of 18 pilot sessions. Both women and health care workers reported group postpartum and well-child care was highly acceptable, appropriate, and feasible across clinics. Fidelity to the group care model was high. During each session as part of structured observation the research team noted common health issues, the most common one among women was high blood pressure and among infants was flu-like symptoms. The most common services received within the group space was family planning and infant vaccinations. Women reported gaining knowledge from health promotion group discussions and activities. There were some challenges implementing group sessions. Conclusion We found that clinics in Blantyre District, Malawi were able to implement group postpartum and well-child care with fidelity and that it was highly acceptable, appropriate, and feasible to women and health care workers. Due to these promising results, we recommend future research examine the effectiveness of the model on maternal and child health outcomes.
Evaluation of a midwifery network to guarantee outpatient postpartum care: a mixed methods study. [2020]The necessity of outpatient postpartum care has increased due to shorter hospital stays. In a health care system, where postpartum care after hospital discharge must be arranged by families themselves, this can be challenging for those experiencing psychosocial disadvantages. Therefore, we compared characteristics of users of a midwifery network which referred women to outpatient postpartum care providers with those of women organising care themselves. Additionally, we investigated benefits of the network for women and health professionals.
Telehealth Care for Mothers and Infants to Improve the Continuum of Care: Protocol for a Quasi-Experimental Study. [2023]Ensuring an appropriate continuum of care in maternal, newborn, and child health, as well as providing nutrition care, is challenging in remote areas. To make care accessible for mothers and infants, we developed a telehealth care system called Portable Health Clinic for Maternal, Newborn, and Child Health.
Dyadic Care Mobile Units: A Collaborative Midwifery and Pediatric Response to the COVID-19 Pandemic. [2023]Often dubbed the fourth trimester, the first 6 weeks of the postpartum period is a critical time that sets the stage for future health outcomes for both women and children. Leading maternal and child health advocates agree that intervention in the first 6 weeks of life is crucial. Although most new parents prioritize their newborn's well-care, many postpartum patients do not attend appointments for themselves, missing critical opportunities for identification and treatment of leading causes of maternal morbidity and mortality. Racial disparities in rates of postpartum complications highlight the increased importance of close postpartum follow-up for women of color. Barriers to attending routine postpartum visits were exacerbated by the coronavirus disease 2019 (COVID-19) pandemic. Additionally, in traditional models of care, maternal-infant dyads experience fragmented care across multiple departments and patient care settings and only 1 to 2 routine visits for the postpartum patient. To address the challenges of providing in-person postpartum care during the COVID-19 pandemic in Boston, the Midwifery Service, and the Pediatrics Department of Boston Medical Center partnered to launch a mobile postpartum clinic that provided comprehensive, high-touch, dyadic care to postpartum patients and newborns in the first 6 weeks of life. Integrative mobile visits catered to the interplay of maternal and newborn health in the early postpartum period, providing an average of 3 visits to each dyad. This novel clinic concept addresses structural inequities by decreasing barriers to care and reimagines an ideal state of postpartum dyadic care with frequent visits addressing the complete needs of each postpartum patient and newborn. For more than 2 decades, maternal health advocates have been calling for change from health care birth systems to improve health care outcomes. This collaborative, interdepartmental initiative-conceived in the context of a pandemic-is an answer to that call.
Creating New Strategies to Enhance Postpartum Health and Wellness. [2022]Over the past 5 years there have been a number of new initiatives focused on improving birth outcomes and reducing infant mortality, including a renewed focus on the complex interactions between motherhood and infancy that influence lifelong health trajectories. Beginning in 2012, the Association of Maternal & Child Health Programs (AMCHP) facilitated a series of meetings to enhance coordination across initiatives. Emerging from these conversations was a shared desire across stakeholders to reimagine the postpartum visit and improve postpartum care and wellness. AMCHP convened a Postpartum Think-Tank Meeting in 2014 to map the system of postpartum care and identify levers for its transformation. The meeting findings are presented in an infographic which frames the challenges and proposed solutions from the woman's perspective. The infographic describes maternal issues and concerns along with a concise summary of the recommended solutions. Strategies include creating integrated services and seamless care transitions from preconception through postpartum and well-baby; business, community, and government support, including paid parental leave, health insurance and spaces for new parents to meet each other; and mother-centered care, including quality visits on her schedule with complete and culturally appropriate information. These solutions catalyze a postpartum system of care that supports women, children, and families by infusing new ideas and capitalizing on existing opportunities and resources.