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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Ripening
Induction of Labor
Interventions Other: weighted bag
Other: leg taping
Enrollment 197
Recruitment Details We performed a single-site randomized controlled trial at MetroHealth Medical Center, a tertiary hospital, from December 2009 to July 2012.
Pre-assignment Details Eligibility criteria included: admission for an induction of labor, a fetus in cephalic presentation, and an unripe cervix defined as a Bishop score ≤ 6.
Arm/Group Title Weighted Bag (Traction) Leg Taping (Taping)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 99 98
Completed 96 95
Not Completed 3 3
Reason Not Completed
Physician Decision             1             1
ineligible for study             2             2
Arm/Group Title Weighted Bag (Traction) Leg Taping (Taping) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 99 98 197
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 98 participants 197 participants
<=18 years
2
   2.0%
2
   2.0%
4
   2.0%
Between 18 and 65 years
97
  98.0%
96
  98.0%
193
  98.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants 98 participants 197 participants
25.7  (6.9) 25.5  (5.9) 25.6  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 98 participants 197 participants
Female
99
 100.0%
98
 100.0%
197
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 99 participants 98 participants 197 participants
99 98 197
1.Primary Outcome
Title Time to Delivery
Hide Description [Not Specified]
Time Frame an average of 20 hours, up to 40 hours
Hide Outcome Measure Data
Hide Analysis Population Description
In order to find a 20% difference with a 40% standard deviation, power of 90%, and alpha of 0.05, we estimated we needed 86 patients in each arm. We aimed to recruit 194 patients to account for potential dropouts and missing data.
Arm/Group Title Weighted Bag (Traction) Leg Taping (Taping)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Mean (Standard Deviation)
Unit of Measure: hours
19.8  (8.5) 18.8  (8.0)
2.Secondary Outcome
Title Patient Pain/Comfort Rating
Hide Description 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 Frame an average of 20 hours, up to 40 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All patients had pain scores recorded and used in analysis. The values in the table represented the recorded data available and used in the analysis.
Arm/Group Title Weighted Bag (Traction) Leg Taping (Taping)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Median (Full Range)
Unit of Measure: units on a scale
5
(0 to 10)
5
(0 to 10)
3.Secondary Outcome
Title Time to Foley Expulsion
Hide Description time from Foley placement until it is spontaneously expulsed from the cervix
Time Frame an average of 2 hours, up to 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Weighted Bag (Traction) Leg Taping (Taping)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Median (Full Range)
Unit of Measure: hours
1.5
(0.1 to 6.3)
2.6
(0.2 to 10.8)
4.Other Pre-specified Outcome
Title Maternal Morbidities
Hide Description post-partum hemorrhage, clinical chorionamnionitis, endomyometritis, cervical laceration, second procedure, readmission, DVT
Time Frame 30 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Weighted Bag (Traction) Leg Taping (Taping)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 96 95
Measure Type: Number
Unit of Measure: diagnoses
17 16
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Weighted Bag (Traction) Leg Taping (Taping)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Weighted Bag (Traction) Leg Taping (Taping)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Weighted Bag (Traction) Leg Taping (Taping)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)   0/95 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Weighted Bag (Traction) Leg Taping (Taping)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/96 (0.00%)   0/95 (0.00%) 
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.
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
Layout table for Results Point of Contact information
Name/Title: Kelly S Gibson, MD
Organization: Metrohealth Medical Center
Phone: 216-778-5498
EMail: kgibson@metrohealth.org
Publications:
Layout table for additonal information
Responsible Party: Kelly S Gibson, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT00976703     History of Changes
Other Study ID Numbers: IRB09-00392
First Submitted: September 11, 2009
First Posted: September 14, 2009
Results First Submitted: February 26, 2013
Results First Posted: June 3, 2013
Last Update Posted: June 7, 2013