Trial Outcomes & Findings for Induction of Labor With Oxytocin: When Should Oxytocin be Held? (NCT NCT00957593)
NCT ID: NCT00957593
Last Updated: 2019-04-23
Results Overview
Mode of delivery is the primary outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
252 participants
Primary outcome timeframe
24-72 hours from admission for induction
Results posted on
2019-04-23
Participant Flow
ROUTINE oxytocin 127 Discontinuation of oxytocin 125
Participant milestones
| Measure |
Oxytocin
Continuation of oxytocin per protocol once the patient reaches active labor
|
Oxytocin Discontinuation
Oxytocin will be stopped once the patient reaches active labor
|
|---|---|---|
|
Overall Study
STARTED
|
127
|
125
|
|
Overall Study
COMPLETED
|
127
|
125
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Induction of Labor With Oxytocin: When Should Oxytocin be Held?
Baseline characteristics by cohort
| Measure |
Oxytocin
n=127 Participants
Continuation of oxytocin per protocol once the patient reaches active labor
|
Oxytocin Discontinuation
n=125 Participants
Oxytocin will be stopped once the patient reaches active labor
|
Total
n=252 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
|
127 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
252 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 5.6 • n=99 Participants
|
27.7 years
STANDARD_DEVIATION 5.7 • n=107 Participants
|
27.4 years
STANDARD_DEVIATION 0.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
127 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
252 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
United States
|
127 participants
n=99 Participants
|
125 participants
n=107 Participants
|
252 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24-72 hours from admission for inductionMode of delivery is the primary outcome
Outcome measures
| Measure |
Oxytocin
n=127 Participants
Continuation of oxytocin per protocol once the patient reaches active labor
|
Oxytocin Discontinuation
n=125 Participants
Oxytocin will be stopped once the patient reaches active labor
|
|---|---|---|
|
Cesarean Delivery
|
32 Cesarean deliveries
|
24 Cesarean deliveries
|
SECONDARY outcome
Timeframe: 24-72 hoursPopulation: Routine use of oxytocin vs discontinuation of oxytocin once in active labor 127 ROUTINE 125 discontinuation
Perinatal outcomes for patients included in the randomized trial
Outcome measures
| Measure |
Oxytocin
n=127 Participants
Continuation of oxytocin per protocol once the patient reaches active labor
|
Oxytocin Discontinuation
n=125 Participants
Oxytocin will be stopped once the patient reaches active labor
|
|---|---|---|
|
Perinatal Outcomes
Male gender
|
70 Participants
|
66 Participants
|
|
Perinatal Outcomes
Neonatal resuscitation
|
9 Participants
|
7 Participants
|
|
Perinatal Outcomes
Admission to NICU
|
10 Participants
|
9 Participants
|
|
Perinatal Outcomes
Neonatal antibiotic use
|
9 Participants
|
16 Participants
|
Adverse Events
Oxytocin Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin Discontinuation
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