An interventional study of Perinatal health screening and Support services in Perinatal Outcomes, Social Determinants of Health (SDOH) and Health Disparity, Minority and Vulnerable Populations, sponsored by Women and Infants Hospital of Rhode Island. Recruiting at 7 sites in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Treatment
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.
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.
Women and Infants Hospital of Rhode Island is the lead sponsor of 92 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be screened by nurses at the first prenatal visit and repeated in the second trimester, third trimester, at delivery and at 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. Patients who screen positive 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. 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
Other: Perinatal health screening · Other: Support services
No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention
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.
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
Rate of severe maternal morbidity and mortality
any severe maternal morbidity or mortality
Time frame: from enrollment through 1 year postpartum
SDOH screening - Number of prenatal clinics in Rhode Island where COMSS bundle is operational
Time frame: from enrollment through 6 weeks postpartum
SDOH screening - # birthing persons screened
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
Time frame: from enrollment through 6 weeks postpartum
SDOH screening - # receiving case management
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
Time frame: from enrollment through 6 weeks postpartum
Rate of cesarean births among low-risk nulliparous patients
Time frame: delivery
Proportion of patients who receive adequate prenatal care
Time frame: from enrollment through date of delivery
Proportion of patients who get screened for postpartum depression
any depression screening
Time frame: from 4-8 weeks postpartum
Proportion of pregnant people abstinent from alcohol
no alcohol use during pregnancy (based on routine screening measures and information available in medical record)
Time frame: from enrollment through date of delivery
Proportion of pregnant people abstinent from illicit drugs
no use of any illicit drugs during pregnancy (based on routine screening measures and information available in medical record)
Time frame: from enrollment through date of delivery
Infant death
Time frame: delivery through 1 year of life
Preterm birth
Birth at \<37 weeks GA
Time frame: Delivery
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Women and Infants Hospital of Rhode Island