Trial Outcomes & Findings for Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation (NCT NCT02487797)
NCT ID: NCT02487797
Last Updated: 2022-02-11
Results Overview
Number of participants delivered by cesarean section
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1003 participants
Primary outcome timeframe
At time of delivery
Results posted on
2022-02-11
Participant Flow
Participant milestones
| Measure |
High Dose Oxytocin Regimen
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Overall Study
STARTED
|
502
|
501
|
|
Overall Study
COMPLETED
|
502
|
501
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data missing for 6 participants
Baseline characteristics by cohort
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Total
n=1003 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 4.4 • n=502 Participants
|
31.7 years
STANDARD_DEVIATION 4.3 • n=501 Participants
|
31.6 years
STANDARD_DEVIATION 4.4 • n=1003 Participants
|
|
Sex: Female, Male
Female
|
502 Participants
n=502 Participants
|
501 Participants
n=501 Participants
|
1003 Participants
n=1003 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=502 Participants
|
0 Participants
n=501 Participants
|
0 Participants
n=1003 Participants
|
|
Race/Ethnicity, Customized
White
|
332 Participants
n=502 Participants
|
342 Participants
n=501 Participants
|
674 Participants
n=1003 Participants
|
|
Race/Ethnicity, Customized
Black
|
36 Participants
n=502 Participants
|
44 Participants
n=501 Participants
|
80 Participants
n=1003 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latina
|
27 Participants
n=502 Participants
|
26 Participants
n=501 Participants
|
53 Participants
n=1003 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
42 Participants
n=502 Participants
|
47 Participants
n=501 Participants
|
89 Participants
n=1003 Participants
|
|
Race/Ethnicity, Customized
Other, unknown, or more than one race
|
65 Participants
n=502 Participants
|
42 Participants
n=501 Participants
|
107 Participants
n=1003 Participants
|
|
Married or living with a partner
|
396 Participants
n=502 Participants
|
409 Participants
n=501 Participants
|
805 Participants
n=1003 Participants
|
|
Insurance type
Commercial
|
435 Participants
n=502 Participants
|
442 Participants
n=501 Participants
|
877 Participants
n=1003 Participants
|
|
Insurance type
Government
|
66 Participants
n=502 Participants
|
59 Participants
n=501 Participants
|
125 Participants
n=1003 Participants
|
|
Insurance type
Uninsured
|
1 Participants
n=502 Participants
|
0 Participants
n=501 Participants
|
1 Participants
n=1003 Participants
|
|
Body mass index at trial entry
|
28.8 kg/m^2
n=498 Participants • Data missing for 6 participants
|
29.9 kg/m^2
n=499 Participants • Data missing for 6 participants
|
29.2 kg/m^2
n=997 Participants • Data missing for 6 participants
|
|
Gestational or pre-gestational diabetes
|
12 Participants
n=502 Participants
|
15 Participants
n=501 Participants
|
27 Participants
n=1003 Participants
|
|
Chronic hypertension
|
6 Participants
n=502 Participants
|
4 Participants
n=501 Participants
|
10 Participants
n=1003 Participants
|
|
Hypertensive disorders of pregnancy
|
47 Participants
n=502 Participants
|
63 Participants
n=501 Participants
|
110 Participants
n=1003 Participants
|
|
Group B Streptococcus carrier
|
95 Participants
n=492 Participants • Data missing for total of 25 participants
|
88 Participants
n=486 Participants • Data missing for total of 25 participants
|
183 Participants
n=978 Participants • Data missing for total of 25 participants
|
|
Gestational age at trial entry (weeks)
|
39.1 weeks
STANDARD_DEVIATION 0.8 • n=502 Participants
|
39.1 weeks
STANDARD_DEVIATION 0.7 • n=501 Participants
|
39.1 weeks
STANDARD_DEVIATION 0.7 • n=1003 Participants
|
|
Indication for trial entry
Labor with intact membranes
|
236 Participants
n=502 Participants
|
241 Participants
n=501 Participants
|
477 Participants
n=1003 Participants
|
|
Indication for trial entry
Spontaneous rupture of membranes
|
266 Participants
n=502 Participants
|
260 Participants
n=501 Participants
|
526 Participants
n=1003 Participants
|
|
Receipt of magnesium sulfate infusion
|
10 Participants
n=502 Participants
|
13 Participants
n=501 Participants
|
23 Participants
n=1003 Participants
|
|
Neuraxial analgesia before trial entry
|
246 Participants
n=502 Participants
|
247 Participants
n=501 Participants
|
493 Participants
n=1003 Participants
|
|
Amniotomy before trial entry
|
110 Participants
n=502 Participants
|
125 Participants
n=501 Participants
|
235 Participants
n=1003 Participants
|
|
Female fetal sex
|
268 Participants
n=502 Participants
|
239 Participants
n=501 Participants
|
507 Participants
n=1003 Participants
|
|
Neonatal birthweight
|
3325 grams
n=502 Participants
|
3350 grams
n=501 Participants
|
3335 grams
n=1003 Participants
|
PRIMARY outcome
Timeframe: At time of deliveryNumber of participants delivered by cesarean section
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Number of Participants Delivered by Cesarean
|
73 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Number of hours from randomization to deliveryTime from randomization to delivery
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Labor Augmentation Duration
|
9.1 hours
Standard Deviation 5.6
|
10.5 hours
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: From date of delivery to date of hospital discharge, an expected average of 3 daysEstimated blood loss greater than 500 milliliters after a vaginal delivery or greater than 1000 milliliters after a cesarean delivery
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Number of Participants With Postpartum Hemorrhage
|
29 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From time of labor admission to time of delivery, an expected average of 24 to 48 hoursFever greater than 100.4 Fahrenheit in the intrapartum period with the initiation of a therapeutic antibiotic regimen in the intrapartum period
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Number of Participants With Intrapartum Chorioamnionitis
|
52 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: From time of delivery to time of hospital discharge, an expected average of 3 daysFever greater than 100.4 Fahrenheit in the postpartum period with the initiation of a therapeutic antibiotic regimen in the postpartum period
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Number of Participants With Postpartum Endometritis
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Study enrollment to delivery (if intrapartum stillbirth) or 28 days of life (if liveborn)Perinatal death includes intrapartum stillbirth and neonatal death
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Number of Participants Whose Offspring Experiences a Perinatal Death
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At time of deliveryUmbilical cord arterial blood pH less than 7.0 or base deficit greater than 12 mmol/L; or cord venous blood pH less than 7.0 or base deficit greater than 12 mmol/L when umbilical artery values are not available
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Number of Participants With Umbilical Cord Acidemia
|
14 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Delivery through 5 minutes of lifeNumber of participants with neonates with Apgar score of less than 3 at 5 minutes of life. This is using a Apgar scale which ranges from minimum total score of 0 and maximum total score of 10, with higher score representing a better outcome.
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Neonatal Apgar Score of Less Than 3 at 5 Minutes of Life
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Delivery to 28 days of lifeNumber of participants whose neonates are admitted to Neonatal Intensive Care Unit
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Admission to Neonatal Intensive Care Unit
|
29 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: Delivery to 28 days of lifeNeonatal composite morbidity will be defined as occurrence of any of the following: perinatal death, severe, respiratory distress, major birth injury, encephalopathy, seizure, need for hypothermic treatment, or sepsis
Outcome measures
| Measure |
High Dose Oxytocin Regimen
n=502 Participants
The oxytocin solution will be prepared using 90 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 6 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 6 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
Low Dose Oxytocin Regimen
n=501 Participants
The oxytocin solution will be prepared using 30 units of oxytocin in 500 milliliters of normal saline (sodium chloride 0.9%). The oxytocin infusion will be initiated with a starting oxytocin concentration rate of 2 milliunits/minute (volume rate 2 milliliters/hour) that can be increased at increments of 2 milliunits/minute (volume rate 2 milliliters/hour) every 15-30 minutes until a labor pattern with uterine contractions every 2-3 minutes of moderate to strong intensity is established.
Oxytocin
Sodium Chloride 0.9%
|
|---|---|---|
|
Number of Participants Whose Neonates Experience a Composite of Severe Neonatal Morbidity and Perinatal Mortality
|
5 Participants
|
7 Participants
|
Adverse Events
High Dose Oxytocin Regimen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Dose Oxytocin Regimen
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