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

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

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

Study Overview

• Status: Completed
• Conditions: Induction of Labor in Multiparous Women
• Intervention / Treatment: Drug: Vaginal Misoprostol; Drug: Intravenous Oxytocin

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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; Other Names: Cytotec
Active Comparator: 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	Drug: Intravenous Oxytocin; 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

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Angela Wilson-Liverman, MSN, CNM, Vanderbilt University

Publications and helpful links

General Publications

• Chaudhuri S, Mitra SN, Banerjee PK, Biswas PK, Bhattacharyya S. Comparison of vaginal misoprostol tablets and prostaglandin E2 gel for the induction of labor in premature rupture of membranes at term: a randomized comparative trial. J Obstet Gynaecol Res. 2011 Nov;37(11):1564-71. doi: 10.1111/j.1447-0756.2011.01575.x. Epub 2011 Jun 16.
• Olagbuji BN, Ezeanochie MC, Kubeyinje W, Dunsin T, Ande AB. Pregnancy outcome following induction of labor with intravaginal misoprostol for decreased fetal movements at term. J Matern Fetal Neonatal Med. 2011 Oct;24(10):1225-7. doi: 10.3109/14767058.2011.572309. Epub 2011 Apr 20.
• Saeed GA, Fakhar S, Nisar N, Alam AY. Misoprostol for term labor induction: a randomized controlled trial. Taiwan J Obstet Gynecol. 2011 Mar;50(1):15-9. doi: 10.1016/j.tjog.2009.08.001.
• Shakya R, Shrestha J, Thapa P. Safety and efficacy of misoprostol and dinoprostone as cervical ripening agents. JNMA J Nepal Med Assoc. 2010 Jan-Mar;49(177):33-7.
• Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD000941. doi: 10.1002/14651858.CD000941.pub2.
• Crane JM, Butler B, Young DC, Hannah ME. Misoprostol compared with prostaglandin E2 for labour induction in women at term with intact membranes and unfavourable cervix: a systematic review. BJOG. 2006 Dec;113(12):1366-76. doi: 10.1111/j.1471-0528.2006.01111.x.
• Lin MG, Nuthalapaty FS, Carver AR, Case AS, Ramsey PS. Misoprostol for labor induction in women with term premature rupture of membranes: a meta-analysis. Obstet Gynecol. 2005 Sep;106(3):593-601. doi: 10.1097/01.AOG.0000172425.56840.57.
• Li XM, Wan J, Xu CF, Zhang Y, Fang L, Shi ZJ, Li K. Misoprostol in labour induction of term pregnancy: a meta-analysis. Chin Med J (Engl). 2004 Mar;117(3):449-52.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 2, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: 120660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO