Trial Outcomes & Findings for Balloon Catheter for Cervical Ripening (NCT NCT02606643)
NCT ID: NCT02606643
Last Updated: 2018-11-07
Results Overview
Hours of labor
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
134 participants
Primary outcome timeframe
hours to delivery 0-26
Results posted on
2018-11-07
Participant Flow
Participant milestones
| Measure |
Group 1 Catheter to Slight Traction
68 patients were analyzed in the tension group
|
Group 2 Catheter to no Traction
76 patients were analyzed in the no tension group
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
76
|
|
Overall Study
COMPLETED
|
67
|
73
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Group 1 Catheter to Slight Traction
68 patients were analyzed in the tension group
|
Group 2 Catheter to no Traction
76 patients were analyzed in the no tension group
|
|---|---|---|
|
Overall Study
did not meet inclusion criteria
|
1
|
3
|
Baseline Characteristics
Balloon Catheter for Cervical Ripening
Baseline characteristics by cohort
| Measure |
Group 1 Catheter to Slight Traction
n=68 Participants
Once the decision was made to use a transcervical catheter and the patient was not in labor, the patient was approached. After informed consent was obtained from each participant, an 18 French 30 cc Foley bulb was placed digitally by the housestaff, with or without a stylette. The balloon was filled with 50 cc of saline as this is the standard at our institution. Patients randomized to tension had their catheter taped with applied tension to the inner thigh. Tension was replaced approximately every 30 minutes as needed. If the catheter was not expelled after12 hours, the balloon was deflated and the catheter was removed.
|
Group 2 Catheter to no Traction
n=76 Participants
Once the decision was made to use a transcervical catheter and the patient was not in labor, the patient was approached. After informed consent was obtained from each participant, an 18 French 30 cc Foley bulb was placed digitally by the housestaff, with or without a stylette. The balloon was filled with 50 cc of saline as this is the standard at our institution. Patients randomized to no tension did not have any tension applied to their catheter. After randomization clinicians were not blinded to the allocated group. If the catheter was not expelled after12 hours, the balloon was deflated and the catheter was removed.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
26 years
n=7 Participants
|
026 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
41 participants
n=5 Participants
|
53 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
76 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Gestational age at enrollment (wk
|
39.1 weeks
n=5 Participants
|
39.0 weeks
n=7 Participants
|
39.05 weeks
n=5 Participants
|
|
Body mass index at admission
|
33.1 kg/m2
n=5 Participants
|
37.0 kg/m2
n=7 Participants
|
35.05 kg/m2
n=5 Participants
|
|
Bishop score at time of transcervical
|
4 units on a scale
n=5 Participants
|
3.5 units on a scale
n=7 Participants
|
3.75 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: hours to delivery 0-26Population: an alpha level of .05, and a level of power of 80%. These parameters required a sample size of 63 patients per group
Hours of labor
Outcome measures
| Measure |
Group 1 Slight Tension
n=67 Participants
Patients randomized to tension had their catheter taped with applied tension to the inner thigh. Tension was replaced approximately every 30 minutes as needed.
|
Group 2 no Tension
n=73 Participants
Patients randomized to no tension did not have any tension applied to their catheter.
|
|---|---|---|
|
Duration
|
16.2 hours
Interval 12.6 to 23.5
|
16.9 hours
Interval 12.4 to 25.6
|
SECONDARY outcome
Timeframe: intraoperativeWhat number of deliveries in the tension and no tension groups were via Cesarean delivery
Outcome measures
| Measure |
Group 1 Slight Tension
n=67 Participants
Patients randomized to tension had their catheter taped with applied tension to the inner thigh. Tension was replaced approximately every 30 minutes as needed.
|
Group 2 no Tension
n=73 Participants
Patients randomized to no tension did not have any tension applied to their catheter.
|
|---|---|---|
|
Deliveries Via Cesarean Delivery
|
17 participants
|
27 participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Twenty four hour Vaginal delivery between groups
vaginal delivery within 24 hours-not all deliveries were within 24hours
Outcome measures
| Measure |
Group 1 Slight Tension
n=52 Participants
Patients randomized to tension had their catheter taped with applied tension to the inner thigh. Tension was replaced approximately every 30 minutes as needed.
|
Group 2 no Tension
n=52 Participants
Patients randomized to no tension did not have any tension applied to their catheter.
|
|---|---|---|
|
Vaginal Delivery Within 24 Hours
|
41 participants
|
37 participants
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
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