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A Randomized, Control Trial for Preinduction Cervical Ripening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00393731
Recruitment Status : Completed
First Posted : October 30, 2006
Last Update Posted : January 16, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.

Condition or disease Intervention/treatment Phase
Labor, Induced Drug: Misoprostol Drug: oxytocin Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: A Randomized, Control Trial for Preinduction Cervical Ripening
Study Start Date : January 2004
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Vaginal Delivery rates

Secondary Outcome Measures :
  1. Time interval to delivery

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Criteria

Inclusion Criteria:

  • Women that are hospitalized for induction of labor that have a Bishop's score <5
  • singleton gestation
  • cephalic presentation
  • 24 weeks gestational age

Exclusion Criteria:

  • Prior uterine surgery
  • malpresentation
  • placenta previa or abruption
  • clinically suspected or diagnosed intra amniotic infection
  • genital HSV infection
  • multiple gestation
  • premature rupture of the membranes
  • active labor
  • maternal/fetal conditions that may preclude labor induction in the opinion of the investigators
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00393731


Locations
United States, Texas
Lyndon B. Johnson Hospital
Houston, Texas, United States, 77026
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Michael Lucas, MD The University of Texas Health Science Center, Houston
More Information

Responsible Party: Michael Lucas, M.D., The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00393731     History of Changes
Other Study ID Numbers: HSC-MS-04-008
First Posted: October 30, 2006    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008

Keywords provided by The University of Texas Health Science Center, Houston:
labor
induction
misoprostol
oxytocin

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