Completed

NCT Number: NCT01634854

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

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

Completed

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Key information

Conditions

Induction of Labor in Multiparous Women

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vaginal Misoprostol

Drug

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

Other names: Cytotec

Intravenous Oxytocin

Drug

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

Other names: Pitocin

Primary outcomes

Time From Induction to Vaginal Delivery

Time frame: 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 outcomes

Neonatal APGAR Scores

Time frame: 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

Time frame: Immediately following delivery

Neonatal Weight
Maternal Delivery Outcomes

Time frame: Through discharge from hospital

Maternal delivery outcomes
Maternal Satisfaction With Labor

Time frame: 6 weeks post-partum
Number of Participants With Excessive Uterine Activity Necessitating Treatment

Time frame: 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

Time frame: Through discharge from hospital

NICU admission and APGAR less than 7 at 5 minutes

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Randomized Comparison of Vaginal Misoprostol and Intravenous Oxytocin for Labor Induction in Multiparous Women

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jul 6, 2012
Registry last updated: Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.