Virtual Doula Services for Maternal Health

(RIVER Trial)

LU
Overseen ByLori Uscher-Pines, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: RAND
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 explores whether virtual doula services can improve birth and postnatal experiences for pregnant women in rural areas. It examines the impact of a virtual doula on birth outcomes, such as cesarean or vaginal delivery, and on new mothers' satisfaction. Participants will receive either support from a virtual doula via a phone app or a free ebook on parenting while continuing their usual care. The trial seeks first-time mothers in their second or early third trimester who reside in rural U.S. zip codes. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance maternal care in rural communities.

Do I need to stop my current medications for the trial?

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

What prior data suggests that virtual doula services are safe for maternal health?

Research shows that virtual doula services can positively affect birth outcomes. Studies have found that having a doula during pregnancy and birth links to fewer C-sections and better results for mothers and babies. While research on virtual doula services is still developing, some studies suggest they might improve maternal health, especially for those with limited access to traditional healthcare. Importantly, no known safety risks exist with using virtual doula services. These services provide support and guidance, not medical treatment, so they are considered safe for expectant mothers.12345

Why are researchers excited about this trial?

Researchers are excited about virtual doula services for maternal health because they offer a personalized support system through a mobile app, which can be accessed anytime during the perinatal period, including postpartum. Unlike traditional in-person doula services, this virtual model provides flexibility and potentially broader access, especially for those in remote areas or with limited mobility. The hope is that this approach will enhance maternal outcomes by providing timely and convenient support, complementing the usual care received during pregnancy and birth.

What evidence suggests that virtual doula services are effective for improving maternal health?

Research has shown that virtual doula services, available to participants in this trial, can improve birth outcomes. Studies have found that a virtual doula is associated with fewer cesarean births and a better overall birth experience. Reviews also highlight that doula support can reduce the likelihood of premature births and aid in breastfeeding. Digital platforms offering virtual doula care provide benefits similar to in-person support. This evidence suggests that virtual doula services could be a valuable tool for enhancing maternal health, particularly in areas with limited resources.14678

Are You a Good Fit for This Trial?

This trial is for pregnant women living in rural areas who are interested in virtual doula support during their pregnancy and birth. Participants should have access to the internet for virtual visits. Specific criteria for joining or reasons someone might not be eligible aren't provided.

Inclusion Criteria

Reside in rural zip codes in the U.S.
I am between 18 and 45 years old.
I am in my second or early third trimester with my first child.

Exclusion Criteria

Working with a doula prior to enrollment
Non-singleton pregnancy
Police custody or incarceration
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 4 scheduled virtual doula visits throughout the perinatal period

Varies throughout perinatal period
Up to 4 virtual visits

Follow-up

Participants are monitored for birth outcomes and postnatal care effectiveness

12 weeks postpartum
Surveys and interviews conducted

What Are the Treatments Tested in This Trial?

Interventions

  • Virtual Doula Services

Trial Overview

The study is testing if having a doula support through video calls can improve birth outcomes like the type of delivery and how satisfied mothers feel about their birth experience, especially in rural communities with less access to care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Doula SupportExperimental Treatment1 Intervention
Group II: Active Comparator ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials
145
Recruited
617,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials
623
Recruited
10,400,000+

Citations

The Impact of Virtual Doula Services on Birth Outcomes in ...

The goal of virtual doula services is to improve access to care in underserved communities and decrease urban-rural differences in key maternal ...

Association Between Doula Use on a Digital Health ...

Virtual doula care provided on a comprehensive digital health platform was associated with reduced odds of cesarean birth and improved birth experience ...

Advancing Equity in Maternal Health With Virtual Doula Care

Several systematic reviews have shown that doula support can reduce cesarean birth rates and premature deliveries and improve breastfeeding ...

Could doulas improve maternal health outcomes in the U.S.?

A recent study published in the American Journal of Public Health suggests doula care may improve maternal health outcomes among Medicaid enrollees.

Driving outcomes with doula support: Maven's research on ...

Virtual doula care is effective and can reduce risk of C-section by a comparable amount to that seen with in-person doula care.

The Effect of Doulas on Maternal and Birth Outcomes

The studies in this review indicated that doula guidance in perinatal care was associated with positive delivery outcomes including reduced cesarean sections.

United States Doula Programs and Their Outcomes

Some studies have found associations between doula care and improved clinical outcomes for birthing people and infants, the evidence is limited.

Doulas, Midwives, and Community Health Workers

Medicaid coverage is linked to 47% fewer C-sections and 29% fewer preterm births, improving outcomes for Medicaid enrollees, especially Black ...