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

This study is currently recruiting participants.
Verified November 2012 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Angela Wilson-Liverman, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01634854
First received: July 2, 2012
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Time from induction to vaginal delivery [ Time Frame: Time to delivery in hours and minutes from initiation of medication ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Maternal satisfaction with labor [ Time Frame: 6 weeks post-partum ] [ Designated as safety issue: No ]
  • Excessive uterine activity necessitating treatment [ Time Frame: Measured from initiation of medication until delivery time ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01634854

Contacts
Contact: Angela Wilson-Liverman, MSN,CNM angela.wilson-liverman@Vanderbilt.Edu

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Sub-Investigator: Kelly A Bennett, MD            
Sub-Investigator: Barry Grimm, DO            
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Angela Wilson-Liverman, MSN, CNM Vanderbilt University
  More Information

Publications:

Responsible Party: Angela Wilson-Liverman, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01634854     History of Changes
Other Study ID Numbers: 120660
Study First Received: July 2, 2012
Last Updated: November 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 21, 2013