A Randomized, Control Trial for Preinduction Cervical Ripening

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00393731
First received: October 26, 2006
Last updated: January 11, 2008
Last verified: January 2008
  Purpose

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 Intervention Phase
Labor, Induced
Drug: Misoprostol
Drug: oxytocin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized, Control Trial for Preinduction Cervical Ripening

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Vaginal Delivery rates

Secondary Outcome Measures:
  • Time interval to delivery

Estimated Enrollment: 540
Study Start Date: January 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Genders 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
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: 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

No publications provided

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
Study First Received: October 26, 2006
Last Updated: January 11, 2008
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 20, 2014