Trial Outcomes & Findings for Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix (NCT NCT00690040)
NCT ID: NCT00690040
Last Updated: 2016-10-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
293 participants
Primary outcome timeframe
At the end of the study
Results posted on
2016-10-24
Participant Flow
Participant milestones
| Measure |
Single Balloon Catheter
Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
|
Double Balloon Catheter
Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
|
|---|---|---|
|
Overall Study
STARTED
|
145
|
148
|
|
Overall Study
COMPLETED
|
145
|
148
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Balloon Catheter Compared With Double Balloon Catheter for Ripening of the Unfavorable Cervix
Baseline characteristics by cohort
| Measure |
Single Balloon Catheter
n=145 Participants
Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
|
Double Balloon Catheter
n=148 Participants
Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
|
Total
n=293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
145 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
293 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
145 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
293 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
145 participants
n=99 Participants
|
148 participants
n=107 Participants
|
293 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At the end of the studyOutcome measures
| Measure |
Single Balloon Catheter
n=145 Participants
Ripening of the unfavorable cervix is done with Single balloon catheter (Foley catheter)
|
Double Balloon Catheter
n=148 Participants
Ripening of the unfavorable cervix is done with double balloon catheter (Atad catheter)
|
|---|---|---|
|
Average Time in Hours From Insertion of the Catheter Until Delivery
|
19.4 HOURS
Standard Deviation 6.0
|
19.1 HOURS
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: At the end of the studyOutcome measures
Outcome data not reported
Adverse Events
Single Balloon Catheter
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Double Balloon Catheter
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place