A Study Comparing Vaginal Misoprostol and Intravenous Oxytocin for Induction of Labor

Vanderbilt University Medical Center130 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Induction of Labor in Multiparous Women

Interventions

Vaginal MisoprostolDRUG

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

Intravenous OxytocinDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Time From Induction to Vaginal Delivery

Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.

Time frame: Time to delivery in minutes from initiation of medication, up to 24 hours

Secondary Outcomes

Neonatal APGAR Scores

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.

Time frame: At 1 minute and 5 minutes after delivery

Neonatal Weight at Delivery

Neonatal Weight

Time frame: Immediately following delivery

Maternal Delivery Outcomes

Maternal delivery outcomes

Time frame: Through discharge from hospital

Maternal Satisfaction With Labor

Time frame: 6 weeks post-partum

Number of Participants With Excessive Uterine Activity Necessitating Treatment

Number of patients receiving terbutaline during labor for uterine tachysytole

Time frame: Measured from initiation of medication until delivery time

NICU Admission and APGAR Less Than 7 at 5 Minutes

NICU admission and APGAR less than 7 at 5 minutes

Time frame: Through discharge from hospital

Data from ClinicalTrials.gov

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