Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Trial of Oral Misoprostol for Labor Augmentation

NCTNCT00906347Other id102008-030

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 350 participants (actual)
Sponsor: University of Texas Southwestern Medical Center · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Dec 2008
Primary completion: Jan 2011
Completion: Jan 2011
First posted: 21 May 2009 (estimated)
Last update posted: 15 Nov 2012 (estimated)
Conditions: Labor Augmentation

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20082009201020112012

Ph 4
A Trial of Oral Misoprostol for Labor Augmentation
NCT00906347
Dec 2008 to Jan 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

MisoprostolDrug
OxytocinDrug

Arms2

Active comparator
Oxytocin augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Active comparator
Misoprostol augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.

Primary outcomes1

Outcomes the sponsor listed as primary.

Uterine Tachysystole
Time frame · Up to four hours after administration of study drug
Registry description
Defined as six contractions in two consecutive 10-minute periods

Secondary outcomes(7)

Infant Apgar Score <4
Time frame · 5 minutes after delivery
Registry description
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.
Umbilical Cord Artery pH <7.1
Time frame · Obtained at delivery
Admission of Neonatal Intensive Care Unit
Time frame · Until hospital discharge
Maternal Chorioamnionitis
Time frame · During labor
Registry description
Temperature 38 degrees C or higher in the absence of other sources of infection
Maternal Hypovolemia Requiring Blood Transfusion
Time frame · Until hospital discharge
Method of Delivery
Time frame · At delivery
Time Elapsed From Start of Labor Augmentation to Delivery
Time frame · Initiation of augmentation until delivery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Up to four hours after administration of study drug

Uterine Tachysystole

Group	Value (participants)
Misoprostol Augmentation	50
Oxytocin Augmentation	41

Secondary and other outcome results(7)

Secondary outcomeNumber· 5 minutes after delivery

Infant Apgar Score <4

Group	Value (infants)
Misoprostol Augmentation	0
Oxytocin Augmentation	0

Secondary outcomeNumber· Obtained at delivery

Umbilical Cord Artery pH <7.1

Group	Value (infants)
Misoprostol Augmentation	3
Oxytocin Augmentation	4

Secondary outcomeNumber· Until hospital discharge

Admission of Neonatal Intensive Care Unit

Group	Value (infants)
Misoprostol Augmentation	1
Oxytocin Augmentation	0

Secondary outcomeNumber· During labor

Maternal Chorioamnionitis

Group	Value (participants)
Misoprostol Augmentation	28
Oxytocin Augmentation	32

Secondary outcomeNumber· Until hospital discharge

Maternal Hypovolemia Requiring Blood Transfusion

Group	Value (participants)
Misoprostol Augmentation	6
Oxytocin Augmentation	2

Secondary outcomeNumber· At delivery

Method of Delivery

Group	Value (participants)
Misoprostol Augmentation	153
Oxytocin Augmentation	154

Secondary outcomeMedian· Initiation of augmentation until delivery

Time Elapsed From Start of Labor Augmentation to Delivery

Group	Value (minutes)
Misoprostol Augmentation	306
Oxytocin Augmentation	276

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Misoprostol AugmentationWomen 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.	–	1 / 176	0 / 176
Oxytocin AugmentationWomen 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	–	2 / 174	0 / 174

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2011

Oral misoprostol for labor augmentation: a randomized controlled trial.

Bleich et al. 2011Obstetrics and gynecologycited by 9

PMID 22105254DOI 10.1097/aog.0b013e318236df5bPUB-22105254

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 16 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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