Clinical trial Recruiting at 3 sites Interventional Women only

Rhode Island community maternal support services

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

Run by Women and Infants Hospital of Rhode Island · NCT07446374 · Data updated 2026-11-12

This program will try adding care coordination, community health workers, doulas, and referrals for housing, food, and transportation to see if that improves perinatal outcomes and reduces racial disparities for pregnant and postpartum people at affiliated Rhode Island clinics.

Quick facts

Study typeInterventional
SexWomen only
Enrollment3000 (estimated)
SponsorWomen and Infants Hospital of Rhode Island
Academic / other
Locations7 sites (Pawtucket, Rhode Island and 6 other locations)
StatusRecruiting
StartedMay 19, 2025
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedMarch 3, 2026
Trial IDNCT07446374 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Birthing people receiving prenatal or postpartum care at Women and Infants Hospital and its affiliated clinics in Rhode Island are the intended participants, especially those with identified social needs.

Probably not a fit

People who receive care outside the participating clinics or who do not have identified social determinants-related needs may be less likely to benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Over four years, a hospital-led team will implement a community-based maternal support services (COMSS) bundle across six affiliated prenatal clinics in Rhode Island. Under a universal screening protocol, patients will be screened at multiple points during pregnancy and postpartum for social determinants of health such as housing, food insecurity, and transportation barriers. The COMSS bundle combines care coordination, community health workers, doula support, and formal referrals and linkages to community-based organizations that address identified needs. Maternal and infant outcomes and racial disparities will be compared before and after program implementation to measure change.

Why it matters

Potential benefit: If successful, the program could reduce adverse maternal and infant outcomes and narrow related racial disparities by addressing social needs alongside clinical care.

How similar studies have gone: Related interventions using doulas, community health workers, and care coordination have shown promising improvements in patient experience and some perinatal outcomes, though integrated multi-site bundles like this remain relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Brown University OBGYN
    Providence, Rhode Island, United States
    Recruiting
  • Women and Infants Hospital of Rhode Island
    Providence, Rhode Island, United States
    Recruiting
  • Providence Community Health Centers - Central
    Providence, Rhode Island, United States
    Recruiting
  • Women's Care
    Pawtucket, Rhode Island, United States
    Not yet recruiting
  • Obstetrics and Gynecology Care Center
    Providence, Rhode Island, United States
    Not yet recruiting
  • Providence Community Health Center - Prairie
    Providence, Rhode Island, United States
    Not yet recruiting
Show 1 more location
  • Care New England Medical Group (CNEMG)
    Warwick, Rhode Island, United States
    Not yet recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.