Pregnancy RelatedNCT06785467
eDoula Feasibility and Acceptability
A study testing eDoula App in people with Pregnancy Related, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- eDoula App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to Jun 2026
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Women's Health Research Unit, 503-494-3666, whru@ohsu.edu
About this study
Official title: 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.
- Conditions
- Pregnancy Related
- Being tested
- eDoula App
- Keywords
- Labor, Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDoula AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: eDoula App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured in the 7 days following delivery
eDoula App Use
The number of days during pregnancy that the eDoula app was used
Measured: Recruitment (19-28 weeks gestation) to delivery
Secondary outcomes (3)
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: 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: 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: Measured in the 7 days following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start23 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Cai, Oregon Health and Science University
- Investigators
- Fei Cai, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785467
- Sponsor's protocol ID
- OHSU IRB 27596
- Status last verified
- Apr 2025
- First submitted
- 16 Jan 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eDoula: The Feasibility and Acceptability of Mobile Application in Pregnancy, Labor, and Birth Support
- ClinicalTrials.gov ID
- NCT06785467
- Acronym / sponsor ID
- OHSU IRB 27596
- Conditions
- Pregnancy Related
- Keywords
- Labor, Birth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Jan 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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –These participants will receive routine pregnancy and delivery care. |
| eDoula Intervention | Experimental | Other: eDoula AppThese participants will have access to the eDoula app during pregnancy. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| eDoula AppeDoula is an app that will give patients reading material and videos to watch based on their due date. It also provides helpful postpartum device. | Other | eDoula Intervention |
Primary outcome
Satisfaction with eDoula app
Time frame: Measured in the 7 days following delivery
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.
eDoula App Use
Time frame: Recruitment (19-28 weeks gestation) to delivery
The number of days during pregnancy that the eDoula app was used
3 secondary outcomes
Labor Agentry Scale-10 (LAS-10)
Time frame: Measured in the 7 days following delivery
Birth Satisfaction Scale-Revised (BSS-R)
Time frame: Measured in the 7 days following delivery
Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Measured in the 7 days following delivery
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 22 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Fei Cai, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eDoula App in people with Pregnancy Related, run by Oregon Health and Science University 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Apr 2025. 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 Women's Health Research Unit Department of Ob/Gyn (503-494-3666, whru@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with eDoula app (time frame: Measured in the 7 days following delivery). The study lists 2 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 22 Apr 2025.