eDoula Feasibility and Acceptability

NCT06785467 | Recruiting

• 1 other identifier: OHSU IRB 27596
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

eDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum guidance. First, patients without access to the app will be recruited and surveyed on their labor and satisfaction outcomes. Then, recruitment will begin for the intervention arm of the study. Participants will be recruited to use the app and complete a survey during the postpartum period.

Conditions

Pregnancy Related

Keywords

Labor; Birth

Outcome Measures

Primary Outcomes (2)

• Satisfaction with eDoula app

  Participant-reported satisfaction with the eDoula app using a 3-question Likert scale. Scores can have a value from 3 to 15, with a higher score indicating greater satisfaction.

  Measured in the 7 days following delivery

• eDoula App Use

  The number of days during pregnancy that the eDoula app was used

  Recruitment (19-28 weeks gestation) to delivery

Secondary Outcomes (3)

• Labor Agentry Scale-10 (LAS-10)

  Measured in the 7 days following delivery

• Birth Satisfaction Scale-Revised (BSS-R)

  Measured in the 7 days following delivery

• Edinburgh Postnatal Depression Scale (EPDS)

  Measured in the 7 days following delivery

Study Arms (2)

Control

NO INTERVENTION

These participants will receive routine pregnancy and delivery care.

eDoula Intervention

EXPERIMENTAL

These participants will have access to the eDoula app during pregnancy.

Other: eDoula App

Interventions

eDoula App OTHER

eDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum device.

eDoula Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous
• Singleton pregnancy
• English speaking
• Own a smart phone or other device capable of downloading and running the eDoula app
• Delivered at 36 weeks 0 days gestation or later
• Able to labor

You may not qualify if:

• Planned cesarean delivery
• Pregnancy complications including placenta accreta spectrum, vasa previa, intrauterine fetal demise, or known major fetal anomaly
• Delivery planned at a location other than Oregon Health and Science University

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Study Officials

• Fei Cai, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Women's Health Research Unit Department of Ob/Gyn

CONTACT

503-494-3666; whru@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control group will receive routine care and will be recruited postpartum to respond to a survey on their labor and satisfaction outcomes. Once control group recruitment is complete, intervention recruitment will begin. Intervention arm participants will gain access to the eDoula app during pregnancy.

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 21, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)