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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
75 micrograms orally every 4 hours for up to 2 doses.
Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Uterine Tachysystole
Defined as six contractions in two consecutive 10-minute periods
Time frame: Up to four hours after administration of study drug
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
Umbilical Cord Artery pH <7.1
Time frame: Obtained at delivery
Admission of Neonatal Intensive Care Unit
Time frame: Until hospital discharge
Maternal Chorioamnionitis
Temperature 38 degrees C or higher in the absence of other sources of infection
Time frame: During labor
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
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