eDoula Feasibility and Acceptability

eDoula: The Feasibility and Acceptability of Mobile Application in Pregnancy, Labor, and Birth Support

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: eDoula App

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Women's Health Research Unit Department of OB/Gyn; Phone Number: 503-494-3666; Email: whru@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Women's Health Research Unit; Phone Number: 503-494-3666; Email: whru@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; These participants will receive routine pregnancy and delivery care.
Experimental: eDoula Intervention; These participants will have access to the eDoula app during pregnancy.	Other: eDoula App; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eDoula App Use	The number of days during pregnancy that the eDoula app was used	Recruitment (19-28 weeks gestation) to delivery
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor Agentry Scale-10 (LAS-10)	Instrument measuring patient control during childbirth. Scores can have a value from 10 to 70, with a higher score indicating a better outcome.	Measured in the 7 days following delivery
Birth Satisfaction Scale-Revised (BSS-R)	Instrument measuring patient satisfaction with the birth experience. Scores can have a value from 0 to 40, with higher scores representing greater birth satisfaction.	Measured in the 7 days following delivery
Edinburgh Postnatal Depression Scale (EPDS)	Instrument measuring postnatal depression symptoms following delivery. Scores can have a falue from 0 to 30, with higher scores representing more symptoms of postnatal depression.	Measured in the 7 days following delivery

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Fei Cai, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 21, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Labor; Birth
• Other Study ID Numbers: OHSU IRB 27596

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No