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A Trial of Oral Misoprostol for Labor Augmentation

A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00906347
Enrollment
350
Registered
2009-05-21
Start date
2008-12-31
Completion date
2011-01-31
Last updated
2012-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Augmentation

Keywords

Labor augmentation, Oral misoprostol

Brief summary

This is a prospective, randomized, controlled trial designed to examine the efficacy of oral misoprostol for labor augmentation compared to a standard regimen of intravenous oxytocin.

Interventions

DRUGMisoprostol

75 micrograms orally every 4 hours for up to 2 doses.

DRUGOxytocin

Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Clinical decision to augment labor * Gestational age \> than or equal to 36 weeks * Singleton gestation * Cephalic presentation * Reassuring fetal heart rate tracing * Cervical dilation between 4 and 8 cm * Ruptured membranes with clear amniotic fluid * Intrauterine pressure catheter in place * Less than 200 MVUs in a 10 minute period * 5 or fewer contractions in a 10 minute period * English or Spanish speaking patient

Exclusion criteria

* Non-reassuring fetal heart rate tracing at time of enrollment * Meconium stained amniotic fluid * Previous uterine incision * Maternal fever (defined as greater than 37.9 C) * Known fetal anomalies * Placenta previa or unexplained vaginal bleeding * Estimated fetal weight of 4,500 grams or more * Abnormal maternal bony pelvis * Grandmultiparity

Design outcomes

Primary

MeasureTime frameDescription
Uterine TachysystoleUp to four hours after administration of study drugDefined as six contractions in two consecutive 10-minute periods

Secondary

MeasureTime frameDescription
Umbilical Cord Artery pH <7.1Obtained at delivery—
Admission of Neonatal Intensive Care UnitUntil hospital discharge—
Maternal ChorioamnionitisDuring laborTemperature 38 degrees C or higher in the absence of other sources of infection
Infant Apgar Score <45 minutes after deliveryAssigned 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.
Method of DeliveryAt delivery—
Time Elapsed From Start of Labor Augmentation to DeliveryInitiation of augmentation until delivery—
Maternal Hypovolemia Requiring Blood TransfusionUntil hospital discharge—

Countries

United States

Participant flow

Recruitment details

Women presenting to Labor and Delivery at Parkland Memorial Hosiptal and who met eligibility requirements were offered participation from Decemeber 2008 through January 2001.

Participants by arm

ArmCount
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.
176
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
174
Total350

Withdrawals & dropouts

PeriodReasonFG000FG001
Received Study Drug8 cm prior to initiation of study drug1830
Received Study DrugNonreassuring fetal heart rate131
Received Study DrugRefused study drug10
Received Study DrugUterine tachysystole or hypertonus80

Baseline characteristics

CharacteristicMisoprostol AugmentationOxytocin AugmentationTotal
Age, Customized24.9 years
STANDARD_DEVIATION 5.8
24.1 years
STANDARD_DEVIATION 5.3
24.5 years
STANDARD_DEVIATION 5.6
Region of Enrollment
United States
176 participants174 participants350 participants
Sex: Female, Male
Female
176 Participants174 Participants350 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1760 / 174
serious
Total, serious adverse events
1 / 1762 / 174

Outcome results

Primary

Uterine Tachysystole

Defined as six contractions in two consecutive 10-minute periods

Time frame: Up to four hours after administration of study drug

Population: Intent to treat

ArmMeasureValue (NUMBER)
Misoprostol AugmentationUterine Tachysystole50 participants
Oxytocin AugmentationUterine Tachysystole41 participants
Secondary

Admission of Neonatal Intensive Care Unit

Time frame: Until hospital discharge

Population: Intent to treat

ArmMeasureValue (NUMBER)
Misoprostol AugmentationAdmission of Neonatal Intensive Care Unit1 infants
Oxytocin AugmentationAdmission of Neonatal Intensive Care Unit0 infants
Secondary

Infant Apgar Score <4

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.

Time frame: 5 minutes after delivery

Population: Intent to treat

ArmMeasureValue (NUMBER)
Misoprostol AugmentationInfant Apgar Score <40 infants
Oxytocin AugmentationInfant Apgar Score <40 infants
Secondary

Maternal Chorioamnionitis

Temperature 38 degrees C or higher in the absence of other sources of infection

Time frame: During labor

Population: Intent to treat

ArmMeasureValue (NUMBER)
Misoprostol AugmentationMaternal Chorioamnionitis28 participants
Oxytocin AugmentationMaternal Chorioamnionitis32 participants
Secondary

Maternal Hypovolemia Requiring Blood Transfusion

Time frame: Until hospital discharge

Population: Intent to treat

ArmMeasureValue (NUMBER)
Misoprostol AugmentationMaternal Hypovolemia Requiring Blood Transfusion6 participants
Oxytocin AugmentationMaternal Hypovolemia Requiring Blood Transfusion2 participants
Secondary

Method of Delivery

Time frame: At delivery

Population: Intent to treat

ArmMeasureGroupValue (NUMBER)
Misoprostol AugmentationMethod of DeliverySpontaneous vaginal153 participants
Misoprostol AugmentationMethod of DeliveryForceps4 participants
Misoprostol AugmentationMethod of DeliveryCesarean for dystocia11 participants
Misoprostol AugmentationMethod of DeliveryCesarean for nonreassuring fetal heart rate8 participants
Oxytocin AugmentationMethod of DeliveryCesarean for nonreassuring fetal heart rate5 participants
Oxytocin AugmentationMethod of DeliverySpontaneous vaginal154 participants
Oxytocin AugmentationMethod of DeliveryCesarean for dystocia13 participants
Oxytocin AugmentationMethod of DeliveryForceps2 participants
Secondary

Time Elapsed From Start of Labor Augmentation to Delivery

Time frame: Initiation of augmentation until delivery

Population: Intent to treat

ArmMeasureValue (MEDIAN)
Misoprostol AugmentationTime Elapsed From Start of Labor Augmentation to Delivery306 minutes
Oxytocin AugmentationTime Elapsed From Start of Labor Augmentation to Delivery276 minutes
Secondary

Umbilical Cord Artery pH <7.1

Time frame: Obtained at delivery

Population: Intent to treat

ArmMeasureValue (NUMBER)
Misoprostol AugmentationUmbilical Cord Artery pH <7.13 infants
Oxytocin AugmentationUmbilical Cord Artery pH <7.14 infants

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026