Perinatal OutcomesRICOMSSNCT07446374
Rhode Island Community-based Maternal Support Services
A study testing Perinatal health screening and Support services in people with Perinatal Outcomes and Social Determinants of Health (SDOH), run by Women and Infants Hospital of Rhode Island at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perinatal Outcomes, Social Determinants of Health (SDOH), Health Disparity, Minority and Vulnerable Populations
- What is being tested?
- Perinatal health screening and Support services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 7 sitesUnited States
- Study dates
- 19 May 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics
Who cannot join
- Anyone not meeting the above criteria
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
Women's Care
Pawtucket, Rhode Island, 02860
401-921-6924
- Recruiting
Brown University OBGYN
Providence, Rhode Island, 02904
LG Ward, 401-606-3000, lgward@brown.edu
- Not yet recruiting
Obstetrics and Gynecology Care Center
Providence, Rhode Island, 02905
Medical Director, (401) 274-1122 ext. 42735
- Not yet recruiting
Providence Community Health Center - Prairie
Providence, Rhode Island, 02905
401-444-0570
- Recruiting
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Methodius Tuuli, MD, MPH, MBA, 401-274-1100, mtuuli@wihri.org
- Recruiting
Providence Community Health Centers - Central
Providence, Rhode Island, 02907
David Mills, 401-444-0580, dmills@providencechc.org
- Not yet recruiting
Care New England Medical Group (CNEMG)
Warwick, Rhode Island, 02886
(401) 737-7000 ext. 48755
About this study
Official title: Rhode Island Community-based Maternal Support Services (RI COMSS) Bundle for Advancing Perinatal Health Equity
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.
Read the detailed description
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.
- Conditions
- Perinatal Outcomes, Social Determinants of Health (SDOH), Health Disparity, Minority and Vulnerable Populations, Pregnancy
- Being tested
- Perinatal health screening, Support services
- Keywords
- pregnancy, social determinants of health, perinatal outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perinatal health screeningOther
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 servicesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Community-based Maternal Support Services (COMSS) model | Experimental | 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 Receives: Other: Perinatal health screening; Other: Support services |
| Baseline | No intervention | No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of severe maternal morbidity and mortality
any severe maternal morbidity or mortality
Measured: from enrollment through 1 year postpartum
Secondary outcomes (10)
SDOH screening - Number of prenatal clinics in Rhode Island where COMSS bundle is operational
Measured: 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
Measured: 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
Measured: from enrollment through 6 weeks postpartum
Rate of cesarean births among low-risk nulliparous patients
Measured: delivery
Proportion of patients who receive adequate prenatal care
Measured: from enrollment through date of delivery
Proportion of patients who get screened for postpartum depression
any depression screening
Measured: 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)
Measured: 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)
Measured: from enrollment through date of delivery
Infant death
Measured: delivery through 1 year of life
Preterm birth
Birth at <37 weeks GA
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start19 May 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will use a hybrid implementation-effectiveness stepped wedge cluster randomized trial design for implementation of the Community-based Maternal Support Services (COMSS) model. In a stepped wedge cluster randomized trial, 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
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Methodius Tuuli, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446374
- Sponsor's protocol ID
- 2146241
- Other IDs
- 1CPIMP21374-01-00
- Acronym
- RICOMSS
- Status last verified
- Mar 2026
- First submitted
- 16 Jul 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhode Island Community-based Maternal Support Services (RI COMSS) Bundle for Advancing Perinatal Health Equity
- ClinicalTrials.gov ID
- NCT07446374
- Acronym / sponsor ID
- RICOMSS / 2146241
- Conditions
- Perinatal Outcomes, Social Determinants of Health (SDOH), Health Disparity, Minority and Vulnerable Populations, Pregnancy
- Keywords
- pregnancy, social determinants of health, perinatal outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will use a hybrid implementation-effectiveness stepped wedge cluster randomized trial design for implementation of the Community-based Maternal Support Services (COMSS) model. In a stepped wedge cluster randomized trial, 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
| Arm | Type | Receives |
|---|---|---|
| Community-based Maternal Support Services (COMSS) model | Experimental | Other: Perinatal health screening, Other: Support servicesPatients 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 |
| Baseline | No intervention | –No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics
Key exclusion criteria (1 listed)
- Anyone not meeting the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perinatal health screeningPatients 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. | Other | Community-based Maternal Support Services (COMSS) model |
| Support servicesPatients 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 | Other | Community-based Maternal Support Services (COMSS) model |
Primary outcome
Rate of severe maternal morbidity and mortality
Time frame: from enrollment through 1 year postpartum
any severe maternal morbidity or mortality
10 secondary outcomes
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
Time frame: from enrollment through 6 weeks postpartum
SDOH screening - # receiving case management
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
Time frame: from 4-8 weeks postpartum
Proportion of pregnant people abstinent from alcohol
Time frame: from enrollment through date of delivery
Proportion of pregnant people abstinent from illicit drugs
Time frame: from enrollment through date of delivery
Infant death
Time frame: delivery through 1 year of life
Preterm birth
Time frame: Delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perinatal health screening and Support services in people with Perinatal Outcomes and Social Determinants of Health (SDOH), run by Women and Infants Hospital of Rhode Island at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of severe maternal morbidity and mortality (time frame: from enrollment through 1 year postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.