CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 134 enrolled
Drug / intervention
Slight traction +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02606643
NCT02606643N/ACompleted

Balloon Catheter for Cervical Ripening With or Without Traction: A Randomized Controlled Trial

St. Louis University·interventional·Posted Nov 17, 2015·Updated Nov 7, 2018

In Brief

A clinical study evaluating Slight traction and Foley Catheter to no traction for Cervical Dilation. Completed, enrolled 134 participants across 1 site.

Detailed Summary

Once admitted, women who will have a transcervical balloon catheter inserted for induction will be approached for participation in this study. If they agree to be take part in this study (tape or no tape) they will be randomized into the study. After the balloon catheter is inserted, the balloon will then be filled with approximately 50-60 mL of normal saline, this is normal procedure. Study related: If randomized to "No Taping" the foley will be positioned comfortable and not placed to tension. For the "Tension" arm, tension will be placed on the balloon catheter, which will then be taped to the patient's inner thigh. The tension will be assessed and retaped as needed approximately every 30 minutes by the research and/or the nursing staff.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 17, 2015
Enrollment StartOct 1, 2014
Primary CompletionJul 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.6 years ago

Interventions

Slight tractionprocedure

Slight traction will be applied to the balloon catheter

Foley Catheter to no tractionprocedure

Foley Catheter to no traction