Recruiting

COMSS

Sponsor:

Women and Infants Hospital of Rhode Island

Code:

NCT07446374

Conditions

Perinatal Outcomes

Social Determinants of Health (SDOH)

Health Disparity, Minority and Vulnerable Populations

Pregnancy

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Perinatal health screening

Support services

Study Details

Brief summary:

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.

Conditions

Perinatal Outcomes

Social Determinants of Health (SDOH)

Health Disparity, Minority and Vulnerable Populations

Pregnancy

Study ID

NCT07446374

Start date

May 19, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Community-based Maternal Support Services (COMSS) model

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

no intervention: Baseline

No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention

Interventions

Perinatal health screening

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

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 outcome measure

  • Rate of severe maternal morbidity and mortality [ Time Frame: from enrollment through 1 year postpartum ]

Central Contacts and Locations

Locations

Brown University OBGYN

Recruiting

Providence, Rhode Island, United States, 02904

Contacts

LG Ward

401-606-3000lgward@brown.edu

Women and Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Methodius Tuuli, MD, MPH, MBA

401-274-1100mtuuli@wihri.org

Providence Community Health Centers - Central

Recruiting

Providence, Rhode Island, United States, 02907

Contacts

David Mills

401-444-0580dmills@providencechc.org

More Information

Sponsor

Women and Infants Hospital of Rhode Island

Last update posted

Mar 3, 2026

Last verified

Mar, 2026

Keywords

  • pregnancy
  • social determinants of health
  • perinatal outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2026-03-03.