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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy; Maternal Health; Telehealth; Birth
• Intervention / Treatment: Other: Ebook; Other: Virtual doula support

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.

• Study Type: Interventional
• Enrollment (Estimated): 614
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lori Uscher-Pines, PhD; Phone Number: 703-413-1100; Email: luscherp@rand.org

Study Locations

• United States
  • Virginia
    • Arlington, Virginia, United States, 22202
      • RAND
      • Contact: RAND Washington Office; Phone Number: 703-413-1100; Email: Health@rand.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Ebook; Participants will receive an ebook on parenting.
Experimental: 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth type	Cesarean or Vaginal Birth	Assessed at 3 weeks postpartum
Birth Satisfaction	Score on Birth Satisfaction Scale-Revised. Scores can range from 0-40, with higher scores indicating greater satisfaction.	Assessed at 3 weeks postpartum
Parental Self-Efficacy	Score on maternal confidence questionnaire. Scores can range from 14 to 70, with higher scores indicating greater maternal confidence.	Assessed at 12 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastfeeding duration	Any breastfeeding (yes/no) in prior 7 days	Assessed at 12 weeks postpartum
Receipt of postnatal care	Attendance at postpartum visit	Assessed at 12 weeks postpartum
Birth Truma	Traumatic birth experience (yes/no)	Assessed at 3 weeks postpartum
Breastfeeding Initiation	Attempted breastfeeding (yes/no)	Assessed at 12 weeks postpartum
Maternal Depression	Score on Edinburgh Depression Scale. Minimum score of 0 and maximum score of 27, with higher scores indicating increased severity of depressive symptoms.	Assessed at 3 weeks postpartum

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: National Institute of Nursing Research (NINR)

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; birth; virtual; maternal health; doula; telehealth
• Other Study ID Numbers: 2R01NR018837-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will provide de-identified patient-level survey data on all primary and and secondary outcomes as well as demographic data. Data will be available in CSV format on the Harvard Data Respository
• IPD Sharing Time Frame: Data will be available one year after the completion of the project and will be available for 5 years.
• IPD Sharing Access Criteria: Access to the scientific data will be made available by the Harvard Data Repository after a request has been submitted and approved by the PIs. To be approved, the requesting organization or individual should demonstrate that they intend to use the data for research purposes and that they have obtained IRB approval.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No