A Trial of Oral Misoprostol for Labor Augmentation
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|ClinicalTrials.gov Identifier: NCT00906347|
Recruitment Status : Completed
First Posted : May 21, 2009
Results First Posted : November 7, 2012
Last Update Posted : November 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Labor Augmentation||Drug: Misoprostol Drug: Oxytocin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled Trial of Oral Misoprostol for Labor Augmentation|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Active Comparator: Oxytocin augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.
Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
Other Name: Pitocin
Active Comparator: Misoprostol augmentation
Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.
75 micrograms orally every 4 hours for up to 2 doses.
Other Name: Cytotec
- Uterine Tachysystole [ Time Frame: Up to four hours after administration of study drug ]Defined as six contractions in two consecutive 10-minute periods
- Infant Apgar Score <4 [ Time Frame: 5 minutes after delivery ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906347
|United States, Texas|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||April Bleich, MD||University of Texas Southwestern Medical Center|
|Study Director:||Kenneth Leveno, MD||University of Texas Southwestern Medical Center|