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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Angela Wilson-Liverman, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT01634854
First received: July 2, 2012
Last updated: May 26, 2017
Last verified: May 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
    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


Enrollment: 130
Study Start Date: July 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01634854

Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Angela Wilson-Liverman, MSN, CNM Vanderbilt University
  More Information

Publications:

Responsible Party: Angela Wilson-Liverman, Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01634854     History of Changes
Other Study ID Numbers: 120660
Study First Received: July 2, 2012
Results First Received: April 14, 2017
Last Updated: May 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on August 16, 2017