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Tracking Information | |||||
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First Received Date † | December 11, 2006 | ||||
Last Updated Date | November 2, 2008 | ||||
Start Date † | August 2004 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00410345 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Cervical Rippening With Antiprogesterone in Midtrimester Abortions | ||||
Official Title † | Cervical Rippening With Antiprogesterone in Midtrimester Abortions | ||||
Brief Summary | Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip. |
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Detailed Description | The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects. |
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Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Abortion, Missed | ||||
Intervention † | Drug: Mifepristone | ||||
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 | ||||
Enrollment † | 50 | ||||
Completion Date | May 2008 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Israel | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00410345 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Hadassah Medical Organization | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Hadassah Medical Organization | ||||
Verification Date | May 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |