Overview

This trial is active, not recruiting.

Condition induction of labor in multiparous women
Treatments vaginal misoprostol, intravenous oxytocin
Sponsor Vanderbilt University
Start date July 2012
End date December 2014
Trial size 136 participants
Trial identifier NCT01634854, 120660

Summary

This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
vaginal misoprostol Cytotec
Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
(Active Comparator)
intravenous oxytocin Pitocin
Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern. Route of administration: intravenous

Primary Outcomes

Measure
Time from induction to vaginal delivery
time frame: Time to delivery in hours and minutes from initiation of medication

Secondary Outcomes

Measure
Maternal and neonatal morbidity
time frame: Through discharge from hospital
Maternal satisfaction with labor
time frame: 6 weeks post-partum
Excessive uterine activity necessitating treatment
time frame: Measured from initiation of medication until delivery time

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Clinical candidate for labor induction utilizing either misoprostol or oxytocin - Greater than or equal to 18 years of age - Multiparous - Singleton gestation; - Greater than 37 weeks gestation; - Cephalic presentation Exclusion Criteria: - Any clinical contraindication to misoprostol as induction drug - Age less than 18 years - Contraindication to vaginal birth - Nonreassuring fetal heart rate tracing - Prior uterine surgery - Active labor - Active maternal bleeding - Chorioamnionitis (infection)

Additional Information

Official title Randomized Comparison of Vaginal Misoprostol and Intravenous Oxytocin for Labor Induction in Multiparous Women
Principal investigator Angela Wilson-Liverman, MSN, CNM
Description Both oxytocin and misoprostol have been demonstrated to be safe and effective methods for induction of labor. A direct comparison of efficacy and time to delivery in multiparas has not been specifically investigated. Additionally, the study will look at costs of the two drugs.Oxytocin is administered through an IV so requires more direct patient care time from the Registered Nurse, IV pump, and tubing, whereas misoprostol is a tablet, administered only once, per vagina or orally, every 4 hours. Misoprostol is also very inexpensive comparatively; if equally or more efficacious than oxytocin, this could demonstrate quite a cost and time savings to Vanderbilt University Medical Center and other institutions. Safety of either drug is not in question.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Vanderbilt University.