Trial Outcomes & Findings for A Trial of Oral Misoprostol for Labor Augmentation (NCT NCT00906347)
NCT ID: NCT00906347
Last Updated: 2012-11-15
Results Overview
Defined as six contractions in two consecutive 10-minute periods
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
350 participants
Primary outcome timeframe
Up to four hours after administration of study drug
Results posted on
2012-11-15
Participant Flow
Women presenting to Labor and Delivery at Parkland Memorial Hosiptal and who met eligibility requirements were offered participation from Decemeber 2008 through January 2001.
Participant milestones
| Measure |
Misoprostol Augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Randomized
STARTED
|
176
|
174
|
|
Randomized
COMPLETED
|
176
|
174
|
|
Randomized
NOT COMPLETED
|
0
|
0
|
|
Received Study Drug
STARTED
|
176
|
174
|
|
Received Study Drug
COMPLETED
|
136
|
143
|
|
Received Study Drug
NOT COMPLETED
|
40
|
31
|
Reasons for withdrawal
| Measure |
Misoprostol Augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Received Study Drug
8 cm prior to initiation of study drug
|
18
|
30
|
|
Received Study Drug
Nonreassuring fetal heart rate
|
13
|
1
|
|
Received Study Drug
Refused study drug
|
1
|
0
|
|
Received Study Drug
Uterine tachysystole or hypertonus
|
8
|
0
|
Baseline Characteristics
A Trial of Oral Misoprostol for Labor Augmentation
Baseline characteristics by cohort
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
24.9 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
24.1 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
24.5 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
176 participants
n=5 Participants
|
174 participants
n=7 Participants
|
350 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to four hours after administration of study drugPopulation: Intent to treat
Defined as six contractions in two consecutive 10-minute periods
Outcome measures
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Uterine Tachysystole
|
50 participants
|
41 participants
|
SECONDARY outcome
Timeframe: 5 minutes after deliveryPopulation: Intent to treat
Assigned on a scale of 0-10 by pediatric provider attending delivery. A lower score reflects need for further resuscitation and is potentially associated with increased risk of adverse neurological outcomes.
Outcome measures
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Infant Apgar Score <4
|
0 infants
|
0 infants
|
SECONDARY outcome
Timeframe: Obtained at deliveryPopulation: Intent to treat
Outcome measures
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Umbilical Cord Artery pH <7.1
|
3 infants
|
4 infants
|
SECONDARY outcome
Timeframe: Until hospital dischargePopulation: Intent to treat
Outcome measures
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Admission of Neonatal Intensive Care Unit
|
1 infants
|
0 infants
|
SECONDARY outcome
Timeframe: During laborPopulation: Intent to treat
Temperature 38 degrees C or higher in the absence of other sources of infection
Outcome measures
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Maternal Chorioamnionitis
|
28 participants
|
32 participants
|
SECONDARY outcome
Timeframe: Until hospital dischargePopulation: Intent to treat
Outcome measures
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Maternal Hypovolemia Requiring Blood Transfusion
|
6 participants
|
2 participants
|
SECONDARY outcome
Timeframe: At deliveryPopulation: Intent to treat
Outcome measures
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Method of Delivery
Spontaneous vaginal
|
153 participants
|
154 participants
|
|
Method of Delivery
Forceps
|
4 participants
|
2 participants
|
|
Method of Delivery
Cesarean for dystocia
|
11 participants
|
13 participants
|
|
Method of Delivery
Cesarean for nonreassuring fetal heart rate
|
8 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Initiation of augmentation until deliveryPopulation: Intent to treat
Outcome measures
| Measure |
Misoprostol Augmentation
n=176 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 Participants
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Time Elapsed From Start of Labor Augmentation to Delivery
|
306 minutes
Interval 150.0 to 534.0
|
276 minutes
Interval 162.0 to 462.0
|
Adverse Events
Misoprostol Augmentation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin Augmentation
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Misoprostol Augmentation
n=176 participants at risk
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses.
|
Oxytocin Augmentation
n=174 participants at risk
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Need for emergent cesarean delivery secondary to nonreassuirng fetal heart rate
|
0.57%
1/176 • Number of events 1 • During study period
|
1.1%
2/174 • Number of events 2 • During study period
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. April Bleich
University of Texas Southwestern Medical Center
Phone: 214-648-2316
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place