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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
Results First Received: February 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cervical Ripening
Induction of Labor
Interventions: Other: weighted bag
Other: leg taping

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We performed a single-site randomized controlled trial at MetroHealth Medical Center, a tertiary hospital, from December 2009 to July 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility criteria included: admission for an induction of labor, a fetus in cephalic presentation, and an unripe cervix defined as a Bishop score ≤ 6.

Reporting Groups
  Description
Weighted Bag (Traction) 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 Taping (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.

Participant Flow:   Overall Study
    Weighted Bag (Traction)     Leg Taping (Taping)  
STARTED     99     98  
COMPLETED     96     95  
NOT COMPLETED     3     3  
Physician Decision                 1                 1  
ineligible for study                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Weighted Bag (Traction) 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 Taping (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.
Total Total of all reporting groups

Baseline Measures
    Weighted Bag (Traction)     Leg Taping (Taping)     Total  
Number of Participants  
[units: participants]
  99     98     197  
Age  
[units: participants]
     
<=18 years     2     2     4  
Between 18 and 65 years     97     96     193  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  25.7  ± 6.9     25.5  ± 5.9     25.6  ± 6.4  
Gender  
[units: participants]
     
Female     99     98     197  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     99     98     197  



  Outcome Measures
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1.  Primary:   Time to Delivery   [ Time Frame: an average of 20 hours, up to 40 hours ]

2.  Secondary:   Patient Pain/Comfort Rating   [ Time Frame: an average of 20 hours, up to 40 hours ]

3.  Secondary:   Time to Foley Expulsion   [ Time Frame: an average of 2 hours, up to 12 hours ]

4.  Other Pre-specified:   Maternal Morbidities   [ Time Frame: 30 days after delivery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Nine patients had minor protocol violations yet were included in the intention to treat analysis. Patients and providers were not be blinded. Our inner city, minority population at a single site may also limit the generalizability of the results.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kelly S Gibson, MD
Organization: Metrohealth Medical Center
phone: 216-778-5498
e-mail: kgibson@metrohealth.org


Publications:

Publications automatically indexed to this study:

Responsible Party: Kelly S Gibson, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00976703     History of Changes
Other Study ID Numbers: IRB09-00392
Study First Received: September 11, 2009
Results First Received: February 26, 2013
Last Updated: May 31, 2013
Health Authority: United States: Institutional Review Board