Cervical Rippening With Antiprogesterone in Midtrimester Abortions - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 11, 2006

Last Updated Date

November 2, 2008

Start Date ^†

August 2004

Current Primary Outcome Measures ^†

success of abortion induction
abortion induction duration

Original Primary Outcome Measures ^†

success of abortion induction
abortion induction duration

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.

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.

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.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

May 2008

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

midtrimester late abortion
midtrimester induced abortion

Exclusion Criteria:

placenta previa
infected abortion
rupture of membranes
s/p cesarean section *2 or more

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00410345

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Hadassah Medical Organization

Collaborators ^††

Investigators ^†

Principal Investigator:

Assaf Ben-Meir, MD

Hadassah Medical Organization, Jerusalem, Israel

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.