Trial Outcomes & Findings for Foley Bulb Traction for Cervical Ripening (NCT NCT00976703)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

197 participants

Primary outcome timeframe

an average of 20 hours, up to 40 hours

Results posted on

2013-06-07

Participant Flow

We performed a single-site randomized controlled trial at MetroHealth Medical Center, a tertiary hospital, from December 2009 to July 2012.

Eligibility criteria included: admission for an induction of labor, a fetus in cephalic presentation, and an unripe cervix defined as a Bishop score ≤ 6.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	99	98
Overall Study COMPLETED	96	95
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Physician Decision	1	1
Overall Study ineligible for study	2	2

Baseline Characteristics

Foley Bulb Traction for Cervical Ripening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Weighted Bag (Traction) n=99 Participants 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) n=98 Participants 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 n=197 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	97 Participants n=5 Participants	96 Participants n=7 Participants	193 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	25.7 years STANDARD_DEVIATION 6.9 • n=5 Participants	25.5 years STANDARD_DEVIATION 5.9 • n=7 Participants	25.6 years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	98 Participants n=7 Participants	197 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	99 participants n=5 Participants	98 participants n=7 Participants	197 participants n=5 Participants

PRIMARY outcome

Timeframe: an average of 20 hours, up to 40 hours

Population: 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.

Outcome measures

Outcome measures
Measure	Weighted Bag (Traction) n=96 Participants 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) n=95 Participants 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.
Time to Delivery	19.8 hours Standard Deviation 8.5	18.8 hours Standard Deviation 8.0

SECONDARY outcome

Timeframe: an average of 20 hours, up to 40 hours

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Weighted Bag (Traction) n=96 Participants 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) n=95 Participants 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.
Patient Pain/Comfort Rating	5 units on a scale Interval 0.0 to 10.0	5 units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: an average of 2 hours, up to 12 hours

time from Foley placement until it is spontaneously expulsed from the cervix

Outcome measures

Outcome measures
Measure	Weighted Bag (Traction) n=96 Participants 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) n=95 Participants 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.
Time to Foley Expulsion	1.5 hours Interval 0.1 to 6.3	2.6 hours Interval 0.2 to 10.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days after delivery

post-partum hemorrhage, clinical chorionamnionitis, endomyometritis, cervical laceration, second procedure, readmission, DVT

Outcome measures

Outcome measures
Measure	Weighted Bag (Traction) n=96 Participants 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) n=95 Participants 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.
Maternal Morbidities	17 diagnoses	16 diagnoses

Adverse Events

Weighted Bag (Traction)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Leg Taping (Taping)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelly S Gibson, MD

Metrohealth Medical Center

Phone: 216-778-5498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place