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

ConditionsBirthTelehealthPregnancyMaternal Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorRAND

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Virtual doula support

    Other intervention

    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 intervention

    Participants will receive an ebook on parenting.

Treatment groups

614 Participants
are divided into 2 treatment groups
Group A: Active Comparator ArmActive comparator 1 intervention
Group B: Virtual Doula SupportExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Birth type

Cesarean or Vaginal Birth

Time frame
Assessed at 3 weeks postpartum
2

Birth Satisfaction

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

Time frame
Assessed at 3 weeks postpartum
3

Parental Self-Efficacy

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

Time frame
Assessed at 12 weeks postpartum

Secondary outcomes

1

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.

Time frame
Assessed at 3 weeks postpartum
2

Breastfeeding duration

Any breastfeeding (yes/no) in prior 7 days

Time frame
Assessed at 12 weeks postpartum
3

Receipt of postnatal care

Attendance at postpartum visit

Time frame
Assessed at 12 weeks postpartum
4

Birth Truma

Traumatic birth experience (yes/no)

Time frame
Assessed at 3 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RAND

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: