Trial Outcomes & Findings for Tension Versus Tension- Free Foley Balloon for Cervical Ripening (NCT NCT05404776)
NCT ID: NCT05404776
Last Updated: 2025-08-06
Results Overview
Time to vaginal delivery measured from time of initial Foley balloon placement to delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
279 participants
Primary outcome timeframe
Foley bulb placement to vaginal delivery, up to 24 Hours
Results posted on
2025-08-06
Participant Flow
The intervention is assigned at the cluster (weekly) level; the total number of participants enrolled will be reported as a single total and not separated by clusters.
Participant milestones
| Measure |
Without Tension (Tension Free)
A Foley balloon is introduced into the cervix either manually or under direct visualization, but the foley will not be taped or under tension.
Placement of Foley balloon for cervical ripening without tension. A Foley balloon will be placed for cervical ripening without tension.
|
Tension
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Placement of Foley balloon for cervical ripening with tension. A Foley balloon will be placed for cervical ripening with tension.
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
138
|
|
Overall Study
COMPLETED
|
141
|
138
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tension Versus Tension- Free Foley Balloon for Cervical Ripening
Baseline characteristics by cohort
| Measure |
Without Tension (Tension Free)
n=141 Participants
The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Placement of Foley balloon for cervical ripening without tension.: A Foley balloon will be placed for cervical ripening without tension.
|
Tension
n=138 Participants
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Placement of Foley balloon for cervical ripening with tension.: A Foley balloon will be placed for cervical ripening with tension.
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23 years
n=93 Participants
|
22 years
n=4 Participants
|
22 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=93 Participants
|
138 Participants
n=4 Participants
|
279 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
94 Participants
n=93 Participants
|
88 Participants
n=4 Participants
|
182 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=93 Participants
|
122 Participants
n=4 Participants
|
237 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
141 Participants
n=93 Participants
|
138 Participants
n=4 Participants
|
279 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Foley bulb placement to vaginal delivery, up to 24 HoursTime to vaginal delivery measured from time of initial Foley balloon placement to delivery
Outcome measures
| Measure |
Without Tension (Tension Free)
n=99 Participants
The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Placement of Foley balloon for cervical ripening without tension.: A Foley balloon will be placed for cervical ripening without tension.
|
Tension
n=91 Participants
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Placement of Foley balloon for cervical ripening with tension.: A Foley balloon will be placed for cervical ripening with tension.
|
|---|---|---|
|
Time to Vaginal Delivery
|
1608 minutes
Interval 430.0 to 3438.0
|
1595.5 minutes
Interval 507.0 to 3323.0
|
SECONDARY outcome
Timeframe: Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours)Request for IV pain medications or epidural following placement of Foley balloon
Outcome measures
| Measure |
Without Tension (Tension Free)
n=141 Participants
The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Placement of Foley balloon for cervical ripening without tension.: A Foley balloon will be placed for cervical ripening without tension.
|
Tension
n=138 Participants
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Placement of Foley balloon for cervical ripening with tension.: A Foley balloon will be placed for cervical ripening with tension.
|
|---|---|---|
|
Number of Participants That Requested Analgesia Following Placement of the Foley Balloon
|
119 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: Placement of Foley balloon until cesarean delivery, up to 24 HoursNumber of participants that had a primary cesarean delivery
Outcome measures
| Measure |
Without Tension (Tension Free)
n=141 Participants
The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Placement of Foley balloon for cervical ripening without tension.: A Foley balloon will be placed for cervical ripening without tension.
|
Tension
n=138 Participants
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Placement of Foley balloon for cervical ripening with tension.: A Foley balloon will be placed for cervical ripening with tension.
|
|---|---|---|
|
Number of Participants That Had a Primary Cesarean Delivery
|
42 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Placement of Foley balloon until delivery, up to 24 HoursNumber of participants with chorioamnionitis
Outcome measures
| Measure |
Without Tension (Tension Free)
n=141 Participants
The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Placement of Foley balloon for cervical ripening without tension.: A Foley balloon will be placed for cervical ripening without tension.
|
Tension
n=138 Participants
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Placement of Foley balloon for cervical ripening with tension.: A Foley balloon will be placed for cervical ripening with tension.
|
|---|---|---|
|
Number of Participants With Chorioamnionitis
|
40 Participants
|
48 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Placement of Foley balloon until 24 hours postpartumPopulation: Outcome measure not assessed
Number of participants with postpartum hemorrhage
Outcome measures
Outcome data not reported
Adverse Events
Without Tension (Tension Free)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tension
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