Trial Outcomes & Findings for Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours (NCT NCT03086967)
NCT ID: NCT03086967
Last Updated: 2022-11-30
Results Overview
Time in hours to delivery following use of foley catheter
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
Change in time to delivery following bulb insertion for 6 hours up to 72 hours
Results posted on
2022-11-30
Participant Flow
Participant milestones
| Measure |
Six Hour
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
101
|
|
Overall Study
COMPLETED
|
101
|
99
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Six Hour
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Overall Study
Screen Failure
|
2
|
2
|
Baseline Characteristics
Cervical Ripening With a Double-lumen Balloon Catheter for Six Versus Twelve Hours
Baseline characteristics by cohort
| Measure |
Six Hour
n=101 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.8 years
STANDARD_DEVIATION 5.96 • n=5 Participants
|
24.33 years
STANDARD_DEVIATION 5.92 • n=7 Participants
|
24.6 years
STANDARD_DEVIATION 5.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
49 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Maternal Weight
|
89.0 kg
STANDARD_DEVIATION 20.6 • n=5 Participants
|
85.9 kg
STANDARD_DEVIATION 19.0 • n=7 Participants
|
87.5 kg
STANDARD_DEVIATION 19.8 • n=5 Participants
|
|
Maternal BMI
|
34.1 kg/m^2
STANDARD_DEVIATION 7.5 • n=5 Participants
|
32.7 kg/m^2
STANDARD_DEVIATION 6.6 • n=7 Participants
|
33.4 kg/m^2
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Gestational Age
|
39.4 wks
STANDARD_DEVIATION 1.4 • n=5 Participants
|
39.5 wks
STANDARD_DEVIATION 1.4 • n=7 Participants
|
39.5 wks
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Gravidity
|
1.4 events
STANDARD_DEVIATION 0.9 • n=5 Participants
|
1.4 events
STANDARD_DEVIATION 0.7 • n=7 Participants
|
1.4 events
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Parity
|
0.1 Events
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0.1 Events
STANDARD_DEVIATION 0.4 • n=7 Participants
|
0.1 Events
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Bishop score on admission
|
3.1 Score
STANDARD_DEVIATION 1.5 • n=5 Participants
|
3.2 Score
STANDARD_DEVIATION 1.5 • n=7 Participants
|
3.2 Score
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Indication for Induction
Postdates
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Indication for Induction
Oligohydramnios
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Indication for Induction
Maternal Health Condition
|
62 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Indication for Induction
Fetal Health Condition
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Indication for Induction
Other
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
concomitant medications during induction
Magnesium Sulfate
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
concomitant medications during induction
Pitocin w Foley Bulb
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
concomitant medications during induction
Pitocin after Foley Bulb
|
97 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
concomitant medications during induction
Misoprostol prior to Foley Bulb
|
35 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
concomitant medications during induction
Misoprostol w Foley Bulb
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
concomitant medications during induction
Epidural
|
97 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in time to delivery following bulb insertion for 6 hours up to 72 hoursTime in hours to delivery following use of foley catheter
Outcome measures
| Measure |
Six Hour
n=101 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Time From Foley Bulb Placement to Time of Delivery.
|
24.2 hr
Standard Deviation 10.2
|
24.57 hr
Standard Deviation 10.1
|
PRIMARY outcome
Timeframe: Time (hours) to deliveryOutcome measures
| Measure |
Six Hour
n=13 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=11 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Time to Delivery of Trial of Labor After Cesarean Section
|
20.62 hours
Standard Deviation 8.8
|
27.18 hours
Standard Deviation 11.9
|
PRIMARY outcome
Timeframe: 1 minute Apgar score following birthThe Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Outcome measures
| Measure |
Six Hour
n=13 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=11 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
1 Minute Apgar Score of Trial of Labor After Cesarean Section
|
7.6 score on a scale
Standard Deviation 2.4
|
7.3 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Hour 6, Hour 12Time in hours from foley bulb placement to extrusion
Outcome measures
| Measure |
Six Hour
n=101 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Time From Foley Bulb Placement to Extrusion
|
5.75 hrs
Standard Deviation 0.9
|
9.25 hrs
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Hour Six, Hour 12Outcome measures
| Measure |
Six Hour
n=101 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Mode of Delivery--Number of Participants Having Cesarean Delivery
|
34 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: Hour Six, Hour 12Outcome measures
| Measure |
Six Hour
n=101 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Bacterial Infection (Chorioamnionitis)
|
16 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Hour 6, Hour 12Outcome measures
| Measure |
Six Hour
n=101 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Endometritis
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 minute Apgar score following birthThe Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Outcome measures
| Measure |
Six Hour
n=101 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
1 Minute Apgar Score
|
8 Score
Standard Deviation 1.8
|
7.9 Score
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 5 minute Apgar score following birthThe Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Outcome measures
| Measure |
Six Hour
n=101 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
5 Minute Apgar Score
|
8.8 Score
Standard Deviation 0.7
|
8.8 Score
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Time to foley bulb extrusionOutcome measures
| Measure |
Six Hour
n=13 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=11 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Time to Foley Bulb Extrusion of Trial of Labor After Cesarean Section
|
5.6 hours
Standard Deviation 1.0
|
10.6 hours
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 5 Minute Apgar Score following birthThe Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Outcome measures
| Measure |
Six Hour
n=13 Participants
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=11 Participants
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
5 Minute Apgar Score of Trial of Labor After Cesarean Section
|
8.7 score on a scale
Standard Deviation 0.6
|
8.4 score on a scale
Standard Deviation 2.1
|
Adverse Events
Six Hour
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Twelve Hour
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Six Hour
n=101 participants at risk
Placement of foley catheter and extrusion after 6 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
Twelve Hour
n=99 participants at risk
Placement of foley catheter and extrusion after 12 hours followed by induction.
Double-lumen balloon catheter: introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
incorrect foley placement
|
0.00%
0/101 • Up to 1 year
|
1.0%
1/99 • Up to 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place