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NCT Number: NCT07293741

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Ebook

Other

Participants will receive an ebook on parenting.

Primary outcomes

  1. Birth type

    Time frame: Assessed at 3 weeks postpartum

    Cesarean or Vaginal Birth

  2. Birth Satisfaction

    Time frame: Assessed at 3 weeks postpartum

    Score on Birth Satisfaction Scale-Revised. Scores can range from 0-40, with higher scores indicating greater satisfaction.

  3. Parental Self-Efficacy

    Time frame: Assessed at 12 weeks postpartum

    Score on maternal confidence questionnaire. Scores can range from 14 to 70, with higher scores indicating greater maternal confidence.

Secondary outcomes

  1. Maternal Depression

    Time frame: Assessed at 3 weeks postpartum

    Score on Edinburgh Depression Scale. Minimum score of 0 and maximum score of 27, with higher scores indicating increased severity of depressive symptoms.

  2. Breastfeeding duration

    Time frame: Assessed at 12 weeks postpartum

    Any breastfeeding (yes/no) in prior 7 days

  3. Receipt of postnatal care

    Time frame: Assessed at 12 weeks postpartum

    Attendance at postpartum visit

  4. Birth Truma

    Time frame: Assessed at 3 weeks postpartum

    Traumatic birth experience (yes/no)

  5. Breastfeeding Initiation

    Time frame: Assessed at 12 weeks postpartum

    Attempted breastfeeding (yes/no)

Study contacts

Contact information is provided by the study sponsor or research team.

Lori Uscher-Pines, PhD

CONTACT

[email protected]

703-413-1100

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: RIVER

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 19, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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