The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. The main purpose is to show that oral misoprostol administration is non-inferior to vaginal misoprostol administration with respect to the time interval from misoprostol administration to onset of active phase of labor. The study is a non-inferiority, prospective randomized controlled trial comparing oral misoprostol given as 25 mcg every 2 hours versus vaginal misoprostol given as 25 mcg every 4 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Time to Active Labor
Active phase of labor defined as greater than or equal to 6 cm cervical dilation
Time frame: from start of induction of labor (first misoprostol administration) to active phase of labor, up to 3 days.
Time to Initiation of Oxytocin for Labor Augmentation
The length of time (in hours) between the administration of misoprostol (first dose) and the first administration of oxytocin for labor augmentation.
Time frame: From start of induction of labor (first misoprostol administration) to initiation of oxytocin for labor augmentation, up to 36 hours
Time to Vaginal Delivery
includes vaginal deliveries only; cesarean section deliveries are excluded
Time frame: from start of induction of labor (first misoprostol administration) to vaginal delivery, up to 3 days
Cesarean Section Rate
Number of cesarean sections/total deliveries (%)
Time frame: From enrollment until delivery, up to 3 days
Rate of Tachysystole
Tachysystole is defined as 4 or more contractions in a 10 minute period.
Time frame: from enrollment until delivery, up to 3 days
Rate of Tachysystole Causing Non-reassuring Fetal Heart Tones
Previously defined as "hyperstimulation", this outcome measure is defined as 4 or more contractions in a 10 minute period (tachysystole) thought to be causing recurrent variable or late decelerations, bradycardia, or minimal variability in the fetal heart rate tracing (non-reassuring fetal heart tones,which would require intervention to resolve or delivery of the infant).
Time frame: From enrollment until delivery, up to 3 days
Rate of Need for Tocolysis
Tocolysis is the administration of medication to decrease or stop contractions.
Time frame: from enrollment until delivery, up to 3 days
Rate of Chorioamnionitis
Chorioamnionitis is defined as an intraamniotic infection.
Time frame: from enrollment until delivery, up to 3 days
Rate of Meconium Stained Fluid
Amniotic fluid with visible meconium (from fetal defecation) within it.
Time frame: from enrollment until delivery, up to 3 days
Neonatal Morbidity
binary composite outcome defined as Apgar score \< 7, or cord blood gas pH of less than 7 or base deficit great than 12, or neonatal intensive care unit admission within 4 hours of delivery.
Time frame: 4 hours from delivery
Rate of Anti-emetic Use
Use of medication to treat nausea.
Time frame: from enrollment until delivery, up to 3 days
Rate of Vaginal Delivery Within 24 Hours
Vaginal delivery within from start of induction with misoprostol.
Time frame: 24 hours from start of induction of labor (first misoprostol administration)
Rate of Abandoning Misoprostol for Cervical Ripening and Switching to Mechanical Dilation for Cervical Ripening
Based on clinician's judgment on the progress of the induction, the rate that misoprostol administration was stopped and a cervical ripening balloon was used instead
Time frame: from enrollment until delivery, up to 3 days
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