3000 Participants NeededMy employer runs this trial

Support Services for Pregnancy

(RICOMSS Trial)

Recruiting at 6 trial locations
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: Women and Infants Hospital of Rhode Island
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the health of mothers and babies in Rhode Island by connecting them with community-based maternal support services during and after pregnancy. Hospitals, doulas, and community organizations collaborate to address issues like access to food, housing, and transportation. The trial will compare health outcomes before and after these services to determine if they reduce negative health events and racial disparities. Anyone receiving prenatal or postpartum care at Women and Infants Hospital and its clinics might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and potentially benefit from enhanced support services.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this service delivery model is safe for improving perinatal health outcomes?

Previous studies have shown promising safety results for community-based support services for mothers. Nearly all mothers reported feeling significantly less stressed after joining these programs, and most felt safer. Community health workers and doulas (trained birthing helpers) have improved mothers' physical, mental, and emotional health. These findings suggest that the services are well-received and can enhance the overall health experience for expecting mothers. While more research is always beneficial, existing data provides a strong indication of safety.12345

Why are researchers excited about this trial?

Researchers are excited about the Community-based Maternal Support Services (COMSS) model because it offers a personalized approach to maternal care. Unlike typical prenatal care that may not address social determinants of health, substance use, or mental health, this model screens for these risk factors and actively connects patients with community resources. By utilizing care managers and community health workers for ongoing support and follow-up, the COMSS model aims to improve perinatal outcomes through continuous, tailored care and support throughout pregnancy and postpartum.

What evidence suggests that the Community-based Maternal Support Services model is effective for improving perinatal health outcomes?

Research has shown that community-based support services for mothers, such as the COMSS model tested in this trial, can improve health outcomes for both mothers and babies. Participants in this trial may receive the COMSS model, which involves community health workers and doulas to enhance care and reduce risks during pregnancy. One report highlighted that these services can address critical social issues, such as access to food and housing, which are crucial for healthy pregnancies. Another study found that these models help more women access essential health services. Overall, evidence suggests that community-based support can significantly improve maternal health and help reduce inequalities.26789

Are You a Good Fit for This Trial?

This trial is for anyone receiving pregnancy-related care (before or after birth) at Women and Infants Hospital or its affiliated clinics in Rhode Island.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Throughout pregnancy and postpartum
Screening at first prenatal visit, second trimester, third trimester, delivery, and 2-6 weeks postpartum

Baseline

No active intervention. Data collected to compare to measures post-intervention

Varies by clinic

Community-based Maternal Support Services (COMSS) model

Patients receive care coordination, doula care, and referrals to address SDOH

From enrollment through 3 months postpartum
Weekly or biweekly follow-ups

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year postpartum

What Are the Treatments Tested in This Trial?

Interventions

  • Community-based Maternal Support Services

Trial Overview

The study is testing a bundle of community-based support services, including help from doulas and community health workers, care coordination, and connecting families to resources like food, housing, and transportation. Outcomes before and after the program will be compared.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Community-based Maternal Support Services (COMSS) modelExperimental Treatment2 Interventions
Group II: BaselineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials
119
Recruited
59,200+

Citations

Empowering community-based maternal health research - PMC

This article provides practical insights into how public health institutions can support community-based research and cultivate partnerships to ...

Community-Based Maternal Support Services: The Role of ...

This report explores how community-based doulas and maternity CHWs may provide high-value care that improves maternal health outcomes. For more ...

Community-Based Models Improve Maternal Outcomes ...

Community-based models of care, including group prenatal care and pregnancy medical homes, may improve maternal health outcomes.

Effectiveness of a community-based intervention package in ...

We examined the effectiveness of a community-based intervention package that targeted pregnant women for increasing utilization of maternal health services.

Community‐Based Initiatives to Improve Maternal and ...

✦ Community-based initiatives can be effective in high-income countries (HICs) for improving aspects of maternal and newborn health, ...

Community‐Based Initiatives to Improve Maternal and ... - PMC

To date, 7 randomized control trials (RCTs) have been carried out on PLA, as well as a systematic review and meta‐analysis, showing a 49% reduction in maternal ...

How Community Health Workers Impact Perinatal Mothers ...

Almost all mothers reported significantly reduced stress after joining the program. The majority also reported an improved sense of safety, ...

Promoting Safety in Community-Based Birth Settings

The safety of home or birth center birth can be improved by adequate birth attendant training, access to emergency obstetric care, and careful risk assessment.

Community-Based Doulas are Improving Maternal Mental ...

Doulas have had a resurgence, shown to improve maternal health outcomes, physically, mentally, and emotionally, particularly among underserved populations.