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

NCT07293741 | Not Yet Recruiting

• 1 other identifier: 2R01NR018837-06
• Study Type: interventional
• Target: 614
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth; Telehealth; Pregnancy; Maternal Health

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Maternal Depression

  Assessed at 3 weeks postpartum

• Breastfeeding duration

  Assessed at 12 weeks postpartum

• Receipt of postnatal care

  Assessed at 12 weeks postpartum

• Birth Truma

  Assessed at 3 weeks postpartum

• Breastfeeding Initiation

  Assessed at 12 weeks postpartum

Study Arms (2)

Active Comparator Arm

ACTIVE COMPARATOR

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

Virtual Doula Support

EXPERIMENTAL

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

Interventions

Ebook OTHER

Participants will receive an ebook on parenting.

Active Comparator Arm

Virtual doula support 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.

Virtual Doula Support

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• RAND: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

RAND

Arlington, Virginia, 22202, United States

Location

Central Study Contacts

Lori Uscher-Pines, PhD

CONTACT

703-413-1100; luscherp@rand.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Policy Researcher

Model Details: 2-arm, parallel design

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 19, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available one year after the completion of the project and will be available for 5 years.
• 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.

Locations

US (1)