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NCT02044458 · ClinicalTrials.gov registry record · NA
Foley Catheter for Induction of Labor
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 134
- Enrollment target
NCT02044458: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT02044458 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 134 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02044458, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 134 participants
- Enrollment target
Study Summary
Study Design: Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Detailed Description The utilization of a Foley catheter for induction of labor is well established. There are two techniques readily used for placing a Foley catheter. The most common method is under direct visualization of the cervix during a sterile speculum examination and the other method is to place a catheter during a digital cervical examination. Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The Foley catheter plus rigid stylette technique seems to be an efficient and safe method for labor induction. However, to our knowledge there is no study that assesses the difference between the standard digital placement of a Foley catheter versus the digital placement of a Foley catheter with stylette.
Primary Outcome
Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pai
Interventions
- DEVICE Stylette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-12 |
| Phase | NA |
What the finished NCT02044458 record still lists
NCT02044458 is an interventional study that assigns participants to a tested intervention. The registered 134 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 (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Stylette is the first listed.
NCT02044458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02044458 about?
NCT02044458 is a clinical study titled "Foley Catheter for Induction of Labor". Study Design: Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Detailed Description The utilization of a Foley catheter for induction of labor is well established. There are two techniques readily used for placing a Foley catheter. The ...
What is the current status of trial NCT02044458?
This trial is currently completed. It is a NA study. The enrollment target is 134 participants. The study started on 2013-04. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02044458?
The interventions under investigation include: Stylette (DEVICE).
Who is sponsoring clinical trial NCT02044458?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02044458's enrollment target sits among peer trials
134 728th of 2000 higher than 1,272 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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