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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by Angela Wilson-Liverman, Vanderbilt University.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Angela Wilson-Liverman, Vanderbilt University Identifier:
First received: July 2, 2012
Last updated: December 9, 2014
Last verified: December 2014
This study will compare the effectiveness of vaginal misoprostol (Cytotec) and intravenous oxytocin (Pitocin) in multiparous women who present at term for labor induction.

Condition Intervention
Induction of Labor in Multiparous Women Drug: Vaginal Misoprostol Drug: Intravenous Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Comparison of Vaginal Misoprostol and Intravenous Oxytocin for Labor Induction in Multiparous Women

Resource links provided by NLM:

Further study details as provided by Angela Wilson-Liverman, Vanderbilt University:

Primary Outcome Measures:
  • Time from induction to vaginal delivery [ Time Frame: Time to delivery in hours and minutes from initiation of medication ]
    Comparing the time to delivery in multiparas undergoing induction of labor with vaginal misoprostol or intravenous oxytocin.

Secondary Outcome Measures:
  • Maternal and neonatal morbidity [ Time Frame: Through discharge from hospital ]
  • Maternal satisfaction with labor [ Time Frame: 6 weeks post-partum ]
  • Excessive uterine activity necessitating treatment [ Time Frame: Measured from initiation of medication until delivery time ]

Estimated Enrollment: 136
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vaginal Misoprostol 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 Name: Cytotec
Active Comparator: Intravenous Oxytocin 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 Name: Pitocin

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01634854

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Angela Wilson-Liverman, MSN, CNM Vanderbilt University
  More Information


Responsible Party: Angela Wilson-Liverman, Assistant Professor, Vanderbilt University Identifier: NCT01634854     History of Changes
Other Study ID Numbers: 120660
Study First Received: July 2, 2012
Last Updated: December 9, 2014

Additional relevant MeSH terms:
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents processed this record on June 26, 2017