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NCT04053413 · ClinicalTrials.gov registry record · NA
University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT04053413: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT04053413 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04053413, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean delivery can improve the birth options decision-making process for patients. Participants are screened for eligibility through electronic health records. Once an individual is screened eligible, and email invite is sent providing information about the study and assessing the interest in participation. An on-line consent is completed and women are entered sequentially into the usual care group and then through further recruitment, another sample of women are entered into the decision aid group. The primary outcome is satisfaction with the shared decision-making process with their provider.
Primary Outcome
This is a measure of the patient's involvement in the decision. 1 point is assigned for discussing the pros 'a lot' or 'some'; 1 point is assigned for discussing the cons 'a lot' or 'some'; 1 point is assigned for responding 'yes' if the provider explained the options; and 1 point is assigned for responding 'yes' that the provider asked the patient what treatment she wanted. The tool's score range is 0-4. A higher score indicates more involvement in the decision.
Interventions
- OTHER Decision Aid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-04-16 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
What the finished NCT04053413 record still lists
NCT04053413 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Decision Aid is the first listed.
NCT04053413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04053413 about?
NCT04053413 is a clinical study titled "University of North Carolina-Healthwise Partnership Project on Birth Options Decision Aid". This is pilot quasi-experimental study of women with one or two prior cesarean deliveries who are now pregnant and eligible for a trial of labor after cesarean delivery, to assess whether a decision aid, providing knowledge about trial of labor (VBAC) and planned repeat cesarean delivery can improve...
What is the current status of trial NCT04053413?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2018-04-16. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT04053413?
The interventions under investigation include: Decision Aid (OTHER).
Who is sponsoring clinical trial NCT04053413?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04053413's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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