BirthRIVERNCT07293741
The Impact of Virtual Doula Services on Birth Outcomes in Rural Communities
A study testing Virtual doula support and Ebook in people with Birth and Telehealth, run by RAND at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Birth, Telehealth, Pregnancy
- What is being tested?
- Virtual doula support and Ebook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
RAND
Arlington, Virginia, 22202
RAND Washington Office, 703-413-1100, Health@rand.org
About this study
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.
Read the 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
- Being tested
- Virtual doula support, Ebook
- Keywords
- telehealth, virtual, doula, pregnancy, birth, maternal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual doula supportOther
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.
EbookOther
Participants will receive an ebook on parenting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Virtual doula support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth type
Cesarean or Vaginal Birth
Measured: 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.
Measured: 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.
Measured: Assessed at 12 weeks postpartum
Secondary outcomes (5)
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.
Measured: Assessed at 3 weeks postpartum
Breastfeeding duration
Any breastfeeding (yes/no) in prior 7 days
Measured: Assessed at 12 weeks postpartum
Receipt of postnatal care
Attendance at postpartum visit
Measured: Assessed at 12 weeks postpartum
Birth Truma
Traumatic birth experience (yes/no)
Measured: Assessed at 3 weeks postpartum
Breastfeeding Initiation
Attempted breastfeeding (yes/no)
Measured: Assessed at 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm, parallel design
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Lori Uscher-Pines, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293741
- Sponsor's protocol ID
- 2R01NR018837-06
- Other IDs
- 2R01NR018837-06
- Acronym
- RIVER
- Status last verified
- Jul 2026
- First submitted
- 17 Dec 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Doula Services on Birth Outcomes in Rural Communities
- ClinicalTrials.gov ID
- NCT07293741
- Acronym / sponsor ID
- RIVER / 2R01NR018837-06
- Conditions
- Birth, Telehealth, Pregnancy, Maternal Health
- Keywords
- telehealth, virtual, doula, pregnancy, birth, maternal health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm, parallel design
| Arm | Type | Receives |
|---|---|---|
| Active Comparator Arm | Active comparator | Other: EbookThis arm will receive a free ebook on parenting. The care that they receive for pregnancy and birth will be care as usual. |
| Virtual Doula Support | Experimental | Other: Virtual doula supportThis 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual doula supportParticipants 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. | Other | Virtual Doula Support |
| EbookParticipants will receive an ebook on parenting. | Other | Active Comparator Arm |
Primary outcome
Birth type
Time frame: Assessed at 3 weeks postpartum
Cesarean or Vaginal Birth
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.
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.
5 secondary outcomes
Maternal Depression
Time frame: Assessed at 3 weeks postpartum
Breastfeeding duration
Time frame: Assessed at 12 weeks postpartum
Receipt of postnatal care
Time frame: Assessed at 12 weeks postpartum
Birth Truma
Time frame: Assessed at 3 weeks postpartum
Breastfeeding Initiation
Time frame: Assessed at 12 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual doula support and Ebook in people with Birth and Telehealth, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori Uscher-Pines, PhD (703-413-1100, luscherp@rand.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth type (time frame: Assessed at 3 weeks postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.