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

Study Overview
=================
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.

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

Conditions
-----------------
Induction of Labor in Multiparous Women

Intervention / Treatment
-----------------
* Drug: Vaginal Misoprostol
* Drug: Intravenous Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaginal Misoprostol<br>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 | Drug: Vaginal Misoprostol<br>* 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<br>* Other names: Cytotec;|
| Active Comparator: Intravenous Oxytocin<br>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 | Drug: Intravenous Oxytocin<br>* 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<br>* Other names: Pitocin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time From Induction to Vaginal Delivery | Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin. | Time to delivery in minutes from initiation of medication, up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 1 minute and 5 minutes after delivery | 
| Neonatal Weight at Delivery | Neonatal Weight | Immediately following delivery | 
| Maternal Delivery Outcomes | Maternal delivery outcomes | Through discharge from hospital | 
| Maternal Satisfaction With Labor |  | 6 weeks post-partum | 
| Number of Participants With Excessive Uterine Activity Necessitating Treatment | Number of patients receiving terbutaline during labor for uterine tachysytole | 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 | Through discharge from hospital |