Trial Outcomes & Findings for Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor (NCT NCT02150954)
NCT ID: NCT02150954
Last Updated: 2023-10-26
Results Overview
The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)
Results posted on
2023-10-26
Participant Flow
121 subjects enrolled. Of the 121 subjects 2 were screen failures and 2 subject were excluded after consent due to meeting exclusion criteria.
Participant milestones
| Measure |
Foley Bulb Induction With Low Dose Pitocin
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
59
|
|
Overall Study
COMPLETED
|
57
|
59
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Foley Bulb Induction With Low Dose Pitocin
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Foley Bulb With Low Dose Pitocin Versus Foley Bulb With a Standard Incremental Infusion Protocol for the Induction of Labor
Baseline characteristics by cohort
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
Total
n=116 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
|
57 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
116 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
|
57 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=99 Participants
|
59 participants
n=107 Participants
|
116 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: foley bulb placement until second stage of labor (during admission for delivery, up to approximately 4 days)The second stage of labor was defined as the time from complete cervical dilation to delivery of the fetus.
Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Time to the Second Stage of Labor
|
18.2 hours
Interval 13.6 to 27.8
|
14.6 hours
Interval 9.9 to 28.3
|
PRIMARY outcome
Timeframe: foley bulb placement until delivery (during admission for delivery, up to approximately 4 days)Time from foley balloon placement until neonate delivery
Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Time to Delivery
|
23.7 hours
Interval 13.8 to 30.1
|
19.1 hours
Interval 12.1 to 32.1
|
SECONDARY outcome
Timeframe: during admission for delivery, up to approximately 4 daysNumber of participants having a cesarean delivery
Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Rate of Cesarean Delivery
|
22 participants
|
20 participants
|
SECONDARY outcome
Timeframe: during admission for delivery, up to approximately 4 daysActive labor was defined as the presence of regular, painful contractions and a minimum of 2 cm cervical dilation and complete effacement in nulliparous women or a minimum of 4 cm cervical dilation in multiparous women.
Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Time to Active Labor
|
9.3 hours
Interval 5.8 to 22.4
|
12.2 hours
Interval 6.7 to 23.1
|
SECONDARY outcome
Timeframe: foley bulb placement until removal, up to 10 hoursTime from foley balloon placement until the expulsion or removal of the foley balloon.
Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Time to Foley Expulsion or Removal
|
4.5 hours
Interval 2.7 to 7.5
|
5.6 hours
Interval 3.3 to 8.8
|
SECONDARY outcome
Timeframe: during admission for delivery, up to approximately 4 daysUterine hyperstimulation (tachysystole) was defined as uterine contractions occurring greater than 12 in 20 minutes.
Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Incidence of Uterine Hyperstimulation
|
7 participants
|
11 participants
|
SECONDARY outcome
Timeframe: at time of birth (0 to 1 hour)Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Neonatal Outcome: Birthweight
|
3065 gram
Standard Deviation 530
|
3180 gram
Standard Deviation 511
|
SECONDARY outcome
Timeframe: during admission for delivery, up to approximately 4 daysnumber of participants with placental abruption
Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Neonatal Outcome: Placental Abruption
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: during admission for delivery, up to approximately 4 daysLate fetal heart rate decelerations were defined as a gradual decrease in the fetal heart rate associated with uterine contraction with the nadir of the deceleration occurring after the peak of the contraction.
Outcome measures
| Measure |
Foley Bulb Induction With Low Dose Pitocin
n=57 Participants
Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.
pitocin
|
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
n=59 Participants
Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.
pitocin
|
|---|---|---|
|
Neonatal Outcome: Late Fetal Heart Rate Decelerations
|
14 neonates
|
8 neonates
|
Adverse Events
Foley Bulb Induction With Low Dose Pitocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Foley Bulb With Standard Incremental Pitocin Infusion Protocol
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