Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Foley Bulb Traction for Cervical Ripening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kelly S Gibson, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00976703
First received: September 11, 2009
Last updated: May 31, 2013
Last verified: May 2013

September 11, 2009
May 31, 2013
December 2009
July 2012   (final data collection date for primary outcome measure)
Time to Delivery [ Time Frame: an average of 20 hours, up to 40 hours ] [ Designated as safety issue: No ]
  • time to delivery [ Time Frame: with each case ] [ Designated as safety issue: No ]
  • post-ripening dilation of 3 cm or more [ Time Frame: with each case ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00976703 on ClinicalTrials.gov Archive Site
  • Patient Pain/Comfort Rating [ Time Frame: an average of 20 hours, up to 40 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    time from Foley placement until it is spontaneously expulsed from the cervix
  • patient pain/comfort rating [ Time Frame: with each case ] [ Designated as safety issue: No ]
  • method of delivery [ Time Frame: with each case ] [ Designated as safety issue: No ]
Maternal Morbidities [ Time Frame: 30 days after delivery ] [ Designated as safety issue: No ]
post-partum hemorrhage, clinical chorionamnionitis, endomyometritis, cervical laceration, second procedure, readmission, DVT
Not Provided
 
Foley Bulb Traction for Cervical Ripening
Weighted Bag Versus Inner Thigh Taping for Cervical Ripening With a Foley Catheter Prior to an Induction of Labor

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervical Ripening
  • Induction of Labor
  • 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.
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
August 2012
July 2012   (final data collection date for primary outcome measure)

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)
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00976703
IRB09-00392
No
Kelly S Gibson, MetroHealth Medical Center
MetroHealth Medical Center
Not Provided
Not Provided
MetroHealth Medical Center
May 2013

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