CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 197 enrolled
Drug / intervention
weighted bag +1 moreother
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/NCT00976703
NCT00976703N/ACompleted

Weighted Bag Versus Inner Thigh Taping for Cervical Ripening With a Foley Catheter Prior to an Induction of Labor

MetroHealth Medical Center·interventional·Posted Sep 14, 2009·Updated Jun 7, 2013

In Brief

A clinical study evaluating weighted bag and leg taping for Cervical Ripening and Induction of Labor. Completed, enrolled 197 participants across 1 site.

Detailed Summary

This study aims to determine what type of traction, weighted bag or inner thigh taping, on foley catheters for cervical ripening results in a greater cervical dilation and shorter length of labor. The primary outcomes are post-ripening dilation of 3 cm or more and time to delivery. The secondary outcomes are patient pain/comfort rating and method of delivery. The investigators hypothesize that the use a weighted bag will result in a 20% increase in post-ripening dilation of at least 3 cm and a shorter average length of labor.

Study Details

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

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 14, 2009
Enrollment StartDec 1, 2009
Primary CompletionJul 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 16.8 years ago

Interventions

weighted bagother

For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.

leg tapingother

For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.