A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor
- Conditions
- Induction of Labor in Multiparous Women
- Interventions
- Registration Number
- NCT01634854
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 130
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravenous Oxytocin Intravenous Oxytocin 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 Vaginal Misoprostol Vaginal Misoprostol 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
- Primary Outcome Measures
Name Time Method Time From Induction to Vaginal Delivery Time to delivery in minutes from initiation of medication, up to 24 hours Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.
- Secondary Outcome Measures
Name Time Method Neonatal APGAR Scores At 1 minute and 5 minutes after delivery APGAR is a scoring system that evaluates Activity, Pulse, Grimace, Appearance, and Respiration. Each category is given a score of 0-2 points (with 0 being absent and 2 being normal), the points are then combined for a total score that ranges from 0-10. Scores 7 and above are generally normal, 4 to 6 are fairly low, and 2 and below are considered critically low.
Neonatal Weight at Delivery Immediately following delivery Neonatal Weight
Maternal Delivery Outcomes Through discharge from hospital Maternal delivery outcomes
Maternal Satisfaction With Labor 6 weeks post-partum Number of Participants With Excessive Uterine Activity Necessitating Treatment Measured from initiation of medication until delivery time Number of patients receiving terbutaline during labor for uterine tachysytole
NICU Admission and APGAR Less Than 7 at 5 Minutes Through discharge from hospital NICU admission and APGAR less than 7 at 5 minutes