Birth, Maternal Health, Pregnancy, Telehealth
Conditions
Keywords
telehealth, virtual, doula, pregnancy, birth, maternal health
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.
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.
Interventions
OTHERVirtual 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.
OTHEREbook
Participants will receive an ebook on parenting.
Sponsors
RAND
National Institute of Nursing Research (NINR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
2-arm, parallel design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birth type | Assessed at 3 weeks postpartum | Cesarean or Vaginal Birth |
| Birth Satisfaction | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Maternal Depression | 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. |
| Breastfeeding duration | Assessed at 12 weeks postpartum | Any breastfeeding (yes/no) in prior 7 days |
| Receipt of postnatal care | Assessed at 12 weeks postpartum | Attendance at postpartum visit |
| Birth Truma | Assessed at 3 weeks postpartum | Traumatic birth experience (yes/no) |
| Breastfeeding Initiation | Assessed at 12 weeks postpartum | Attempted breastfeeding (yes/no) |
Countries
United States
Contacts
CONTACTLori Uscher-Pines, PhD
Outcome results
None listed