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| Sponsored by: |
Hadassah Medical Organization |
| Information provided by: | Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00410345 |
Purpose
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.
| Condition | Intervention | Phase |
|
Abortion, Missed |
Drug: Mifepristone |
Phase IV |
| MedlinePlus related topics: | Abortion Pregnancy Loss |
| ChemIDplus related topics: | Mifepristone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Cervical Rippening With Antiprogesterone in Midtrimester Abortions |
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | August 2006 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Arik Tzukert, DMD | 00 972 2 6776095 | arik@hadassah.org.il |
| Contact: Hadas Lemberg, PhD | 00 972 2 6777572 | lhadas@hadassah.org.il |
| Israel | |||||
| Hadassah Medical Organization | Recruiting | ||||
| Jerusalem, Israel | |||||
| Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.ilHadas | |||||
| Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il | |||||
| Principal Investigator: Assaf Ben-Meir, MD | |||||
| Hadassah Medical Organization |
| Principal Investigator: | Assaf Ben-Meir, MD | Hadassah Medical Organization, Jerusalem, Israel |
More Information
| Study ID Numbers: | mifepristoneoxytocin-HMO-CTIL |
| First Received: | December 11, 2006 |
| Last Updated: | May 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00410345 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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