Cervical Rippening With Antiprogesterone in Midtrimester Abortions

This study has been completed.
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
First received: December 11, 2006
Last updated: November 2, 2008
Last verified: May 2008
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Cervical Rippening With Antiprogesterone in Midtrimester Abortions

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • success of abortion induction
  • abortion induction duration

Estimated Enrollment: 50
Study Start Date: August 2004
Study Completion Date: May 2008
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.

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • midtrimester late abortion
  • midtrimester induced abortion

Exclusion Criteria:

  • placenta previa
  • infected abortion
  • rupture of membranes
  • s/p cesarean section *2 or more
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00410345

Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Assaf Ben-Meir, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00410345     History of Changes
Other Study ID Numbers: mifepristoneoxytocin-HMO-CTIL 
Study First Received: December 11, 2006
Last Updated: November 2, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Abortion, Missed
Abortion, Spontaneous
Pregnancy Complications

ClinicalTrials.gov processed this record on May 26, 2016