The Impact of Virtual Doula Services on Birth Outcomes in Rural Communities

NCT ID: NCT07293741

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 614 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-30
• Study Completion Date: 2029-12-31

Brief Summary

This study will assess the impact of virtual doula care on birth and postnatal outcomes among rural mothers. The goal of virtual doula services is to improve access to care in underserved communities and decrease urban-rural differences in key maternal health outcomes including mode of birth (cesarean vs vaginal) and birth satisfaction. By implementing a digital randomized controlled trial, the study team will efficiently recruit a national sample of rural pregnant women to provide evidence of the effectiveness of virtual doula care, the appropriateness of virtual visits for different care and support needs, and the role of virtual care in improving maternal health.

Detailed Description

Rates of maternal morbidity have been rising in the U.S., and there are stark rural-urban differences in cesarean births and adverse pregnancy outcomes. Increasing access to doula care is a promising strategy to improve maternal health. Doulas are non-clinical providers who offer physical, emotional, and informational support throughout the perinatal period. Yet, despite documented evidence of effectiveness, fewer than 10% of U.S. births involve doulas because of costs and workforce shortages. Virtual doula services may increase access to support in communities that lack doulas and decrease costs; however, there is minimal evidence of the effectiveness of this new care model. Lack of research in general, and randomized controlled trials in particular, represents a significant gap given that virtual doula services are currently offered by numerous organizations, and the states and payers adding doula benefits do not have evidence to inform their telehealth policies.

The study team will conduct an innovative digital, parallel design randomized controlled trial (RCT) to assess the impact of virtual doula services in rural communities. Primiparous, pregnant women who live in rural zip codes in the U.S. will be recruited. Recruitment will occur via online research panels. Participants will be randomized to scheduled visits with virtual doulas throughout the perinatal period or to usual care. Birth and postnatal outcomes will be captured via surveys and interviews. This study uses mixed methods and aims to assess the impact of virtual doula services on primary outcomes including type of birth (cesarean vs vaginal), birth satisfaction, and parental self-efficacy and secondary outcomes including maternal depression, breastfeeding initiation and duration, and receipt of prenatal and postnatal care. This study will also explore the acceptability of virtual care for different types of doula visits. Together, these aims will inform policy debates about regulation and reimbursement of doula services that incorporate virtual care.

Conditions

Birth; Telehealth; Pregnancy; Maternal Health

Keywords

telehealth; virtual; doula; pregnancy; birth; maternal health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Active Comparator Arm

This arm will receive a free ebook on parenting. The care that they receive for pregnancy and birth will be care as usual.

Group Type: ACTIVE_COMPARATOR

Ebook

Intervention Type: OTHER

Participants will receive an ebook on parenting.

Virtual Doula Support

This arm will receive up to 4 scheduled visits with doulas via a mobile phone app. Visits can be used any time throughout the perinatal period, including postpartum.

Group Type: EXPERIMENTAL

Virtual doula support

Intervention Type: OTHER

Participants randomized to the intervention arm will receive access to up to 4 scheduled doula visits through Pacify's mobile phone app. All visits will be virtual. Participants may also access the library of resources on the app and text with their doula on demand.

Interventions

Virtual doula support

Participants randomized to the intervention arm will receive access to up to 4 scheduled doula visits through Pacify's mobile phone app. All visits will be virtual. Participants may also access the library of resources on the app and text with their doula on demand.

Intervention Type: OTHER

Ebook

Participants will receive an ebook on parenting.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18-45 years of age
• pregnant (second or early third trimester) with their first child
• reside in a rural zip codes in the U.S.

Exclusion Criteria

• non-singleton pregnancy
• police custody or incarceration
• infant to be separated from mother (e.g., placed for adoption, protective custody)
• working with a doula prior to enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

RAND

OTHER

Sponsor Role: lead

Responsible Party

Lori Uscher-Pines

Senior Policy Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RAND

Arlington, Virginia, United States

Countries

United States

Central Contacts

Lori Uscher-Pines, PhD

Role: CONTACT

Phone: 703-413-1100

Email: luscherp@rand.org

Facility Contacts

RAND Washington Office

Role: primary

Other Identifiers

2R01NR018837-06

Identifier Type: NIH

Identifier Source: secondary_id

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2R01NR018837-06

Identifier Type: NIH

Identifier Source: org_study_id

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