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NCT Number: NCT07446374

Rhode Island Community-based Maternal Support Services

The purpose of this project is to improve perinatal health outcomes in Rhode Island by bringing together the hospital, community health workers (CHWs), doulas, and community-based organizations to build a service delivery model that addresses care coordination and social determinants of health (SDOH) as a part of a concerted effort towards achieving equitable perinatal health outcomes. Over 4 years, the hospital-led project team will implement the community-based maternal support services (COMSS) bundle in 6 affiliated clinics, including care coordination, doula care, and referrals and linkages to community-based organizations that address key SDOH (food, housing, transportation). Maternal and infant health outcomes will be compared pre and post program implementation.

The central hypothesis is that COMSS will reduce adverse maternal and infant outcomes and associated racial disparities.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Care, Pawtucket, Rhode Island, United States

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About this study

Despite a decreasing global trend, maternal mortality (MM) and severe maternal morbidity (SMM) in the United States continue to increase. Black, Indigenous, and People of Color (BIPOC) have disproportionately higher rates of MM. The causes of SMM/MM and the associated disparities are complex and multidimensional, but there is increasing awareness of the important role of social determinants of health (SDOH) - the conditions in which people are born, grow, live, work, and age - on perinatal outcomes. Addressing perinatal health disparities requires a multipronged approach targeting not only the health system and clinical factors that contribute to inadequate care, but also the social needs of patients from communities experiencing disparities.

The purpose of this project is to improve perinatal health outcomes in RI by bringing together the hospital, community health workers (CHWs), doulas, and community-based organizations in participatory model for integrating community-based maternal support services (COMSS). The COMSS program will be implemented in 6 prenatal clinics in Rhode Island.

Under a universal screening protocol, all patients at active COMSS sites will be screened by nurses at the first prenatal visit and repeated in the second trimester, third trimester, at delivery and 2-6 weeks postpartum for three sets of risk factors for adverse perinatal outcomes including high risk SDOH (safe housing, food insecurity, lack of reliable transportation). Patients who screen positive will be assigned to a care manager who will work with CHWs to provide care navigation, care linkage, and connection and/or with community-based partner services to address food, housing and transportation needs. Patients will be followed by the care team until at least 3 months postpartum, when they will be transitioned to primary care.

Randomization into the COMSS program will occur at the clinic level in a stepped wedge cluster randomized trial. All clusters (i.e prenatal clinics) begin the study in baseline conditions and are randomly assigned to cross-over to the intervention condition at pre-determined time points in a sequential, staggered fashion until all groups receive the intervention. Data from all sites will be collected pre and post intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics

Exclusion criteria

  • Anyone not meeting the above criteria

Treatment and study plan

Perinatal health screening

Other

Patients will be screened by nurses at the first prenatal visit and repeated in the second trimester, third trimester, at delivery and 2-6 weeks postpartum for three sets of risk factors for adverse perinatal outcomes - high risk SDOH, substance use and mental health conditions, and high risk pregnancy factors.

Support services

Other

Patients who screen positive for known perinatal risk factors will be assigned to a care manager who will work with community health workers (CHW) to provide care navigation, care linkage, and connection with community-based partner services to address the need identified. Care managers and the CHWs will keep a secure registry of patients and will follow up with them on a weekly or biweekly basis, as appropriate, to ensure continuity of care

Primary outcomes

  1. Rate of severe maternal morbidity and mortality

    Time frame: from enrollment through 1 year postpartum

    any severe maternal morbidity or mortality

Secondary outcomes

  1. SDOH screening - Number of prenatal clinics in Rhode Island where COMSS bundle is operational

    Time frame: from enrollment through 6 weeks postpartum

  2. SDOH screening - # birthing persons screened

    Time frame: from enrollment through 6 weeks postpartum

    Number of birthing persons per year who are screened for high-risk social determinants of health, substance use and behavioral health disorders, and high-risk pregnancy factors

  3. SDOH screening - # receiving case management

    Time frame: from enrollment through 6 weeks postpartum

    Number of individuals per year who receive case management services for addressing high risk SDOH, substance use and behavioral health disorders, and high risk medical and obstetric health diagnoses

  4. Rate of cesarean births among low-risk nulliparous patients

    Time frame: delivery

  5. Proportion of patients who receive adequate prenatal care

    Time frame: from enrollment through date of delivery

  6. Proportion of patients who get screened for postpartum depression

    Time frame: from 4-8 weeks postpartum

    any depression screening

  7. Proportion of pregnant people abstinent from alcohol

    Time frame: from enrollment through date of delivery

    no alcohol use during pregnancy (based on routine screening measures and information available in medical record)

  8. Proportion of pregnant people abstinent from illicit drugs

    Time frame: from enrollment through date of delivery

    no use of any illicit drugs during pregnancy (based on routine screening measures and information available in medical record)

  9. Infant death

    Time frame: delivery through 1 year of life

  10. Preterm birth

    Time frame: Delivery

    Birth at <37 weeks GA

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

Rhode Island Community-based Maternal Support Services (RI COMSS) Bundle for Advancing Perinatal Health Equity

Acronym: RICOMSS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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