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Foley Bulb Traction for Cervical Ripening

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ClinicalTrials.gov Identifier: NCT00976703
Recruitment Status : Completed
First Posted : September 14, 2009
Results First Posted : June 3, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Kelly S Gibson, MetroHealth Medical Center

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Results First Submitted Date  ICMJE February 26, 2013
Results First Posted Date  ICMJE June 3, 2013
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
Time to Delivery [ Time Frame: an average of 20 hours, up to 40 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • post-ripening dilation of 3 cm or more [ Time Frame: with each case ]
  • Time to Delivery [ Time Frame: with each case ]
Change History Complete list of historical versions of study NCT00976703 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2013)
  • Patient Pain/Comfort Rating [ Time Frame: an average of 20 hours, up to 40 hours ]
    Using a visual analog pain scale, with 0 being no pain and 10 being the most severe pain possible, the patients were asked to assess their pain every hour. The highest pain score recorded while the Foley catheter was in place was used. The data are reported as the median and range.
  • Time to Foley Expulsion [ Time Frame: an average of 2 hours, up to 12 hours ]
    time from Foley placement until it is spontaneously expulsed from the cervix
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • Patient Pain/Comfort Rating [ Time Frame: with each case ]
  • method of delivery [ Time Frame: with each case ]
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2013)
Maternal Morbidities [ Time Frame: 30 days after delivery ]
post-partum hemorrhage, clinical chorionamnionitis, endomyometritis, cervical laceration, second procedure, readmission, DVT
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Foley Bulb Traction for Cervical Ripening
Official Title  ICMJE Weighted Bag Versus Inner Thigh Taping for Cervical Ripening With a Foley Catheter Prior to an Induction of Labor
Brief 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.

Detailed Description

Over the last 20 years the number of induced labors doubled so that over one in five births in 2003 was induced. In response to the rising need for cervical ripening the American College Obstetricians and Gynecologists have stated that both mechanical and prostaglandin ripening is acceptable and safe.

Prior to beginning an induction, the Bishop score (cervical dilation, effacement, station, consistency, and position) is assessed. With Bishop scores less than five, a cervical ripening agent is commonly used. The mechanical dilation with a foley catheter works by both a direct stretching of the lower uterine segment and cervix and a local inflammatory response that releases matrix metalloproteinases and prostaglandins. It is often chosen due to its lower cost, low incidence of systemic side effects, and low risk of hyperstimulation.

Compared to misoprostol a foley with oxytocin was more effective at induction in primiparous patients, more effective at improving the dilation, safe to use after misoprostol, and not associated with an increased risk of uterine rupture in a vaginal birth after cesarean (VBAC). The foley was also shown to have a shorter induction time and less contractile abnormalities than prostaglandin E2 gel and no increased rate of uterine rupture in VBAC attempts. The use of extra-amniotic saline infusion with a foley catheter has been used to augment the mechanical stretching, however this did not decrease the induction time or improve the outcomes. Finally, a Cochrane Database review found that mechanical methods of cervical ripening were equally effective as prostaglandin agents.

Although the safety, efficacy, and side effects of foley catheter ripening have been compared with multiple other methods for cervical ripening, very few studies have compared different protocols for foley placement. One study showed that the use of oxytocin while the foley catheter was in place did not significantly shorten the time to delivery. Levy et al showed that a larger, 80 ml, balloon resulted in a greater post-ripening dilation and a higher number of deliveries in 24hours. No study to date has examined how the traction placed on the foley catheter affects the outcome.

Therefore, we propose doing a randomized controlled study in which the control is the current standard of care at MetroHealth Medical Center of placing a 500cc weight on the foley and placing it to gravity over the end of the bed. The comparison will be the method used at many institutions where the foley catheter is placed on gentle traction and taped to the inner thigh of the patient.

The primary outcomes measured will be a post-ripening dilation of 3cm or more and time to delivery. The secondary outcomes are patient pain/comfort rating and method of delivery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cervical Ripening
  • Induction of Labor
Intervention  ICMJE
  • Other: weighted bag
    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.
  • Other: leg taping
    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.
Study Arms  ICMJE
  • Active Comparator: weighted bag
    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.
    Intervention: Other: weighted bag
  • Active Comparator: leg taping
    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.
    Intervention: Other: leg taping
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2012)
197
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2009)
200
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Single viable intrauterine pregnancy
  • Cephalic presentation
  • Bishop score <6
  • Need for induction of labor

Exclusion Criteria:

  • Multiple gestation
  • Bishop score >6
  • Spontaneous labor/regular contractions on admission
  • Rupture of membranes
  • Previous uterine scar
  • Grandmultiparity (greater than 5 deliveries)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976703
Other Study ID Numbers  ICMJE IRB09-00392
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kelly S Gibson, MetroHealth Medical Center
Study Sponsor  ICMJE MetroHealth Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MetroHealth Medical Center
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP