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Tracking Information | |||||
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First Received Date † | October 26, 2006 | ||||
Last Updated Date | January 11, 2008 | ||||
Start Date † | January 2004 | ||||
Current Primary Outcome Measures † |
Vaginal Delivery rates | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00393731 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Time interval to delivery | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | A Randomized, Control Trial for Preinduction Cervical Ripening | ||||
Official Title † | A Randomized, Control Trial for Preinduction Cervical Ripening | ||||
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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Labor, Induced | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Estimated Enrollment † | 540 | ||||
Completion Date | August 2007 | ||||
Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | |||||
Accepts Healthy Volunteers | |||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00393731 | ||||
Responsible Party | Michael Lucas, M.D., The University of Texas Health Science Center, Houston | ||||
Secondary IDs †† | |||||
Study Sponsor † | The University of Texas Health Science Center, Houston | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | The University of Texas Health Science Center, Houston | ||||
Verification Date | January 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |