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

Vanderbilt University Medical Center

Status: Completed

Conditions: Induction of Labor in Multiparous Women

Treatments: Drug: Intravenous Oxytocin; Drug: Vaginal Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01634854

120660

Details and patient eligibility

About

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

Full 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.

Enrollment: 130 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Vaginal Misoprostol

Active Comparator group

Description:

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

Treatment:

Drug: Vaginal Misoprostol

Intravenous Oxytocin

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Oxytocin