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NCT05062343 · ClinicalTrials.gov registry record · NA
Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT05062343: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT05062343 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05062343, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon.
Primary Outcome
Difference in Bishop score calculated from exam at time of device removal minus Bishop score calculated from exam at time of device placement. Bishop score, or cervical score, ranges from a minimum of 0 to maximum of 13. Higher scores indicate that the cervix is more favorable, or ready for labor. Thus, change in Bishop score could range from -13 to +13 with a higher number showing more change in the score, or more cervical ripening.
Interventions
- DEVICE Dilapan-S
- DEVICE Cook Cervical Ripening Balloon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2023-07-19 |
| Phase | NA |
What the finished NCT05062343 record still lists
NCT05062343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Dilapan-S is the first listed.
NCT05062343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05062343 about?
NCT05062343 is a clinical study titled "Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening". The goal of this study is to compare Cook balloon and Dilapan-S for outpatient cervical ripening to see if Dilapan-S is non-inferior in increasing Bishop score compared to the Cook balloon.
What is the current status of trial NCT05062343?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2022-05-01. Estimated completion is 2023-07-19.
What interventions are being tested in trial NCT05062343?
The interventions under investigation include: Dilapan-S (DEVICE), Cook Cervical Ripening Balloon (DEVICE).
Who is sponsoring clinical trial NCT05062343?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05062343's enrollment target sits among peer trials
80 994th of 2000 higher than 941 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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