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Cervical Rippening With Antiprogesterone in Midtrimester Abortions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00410345
First Posted: December 12, 2006
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
December 11, 2006
December 12, 2006
March 1, 2017
August 2004
May 2008   (Final data collection date for primary outcome measure)
  • success of abortion induction
  • abortion induction duration
Same as current
Complete list of historical versions of study NCT00410345 on ClinicalTrials.gov Archive Site
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Cervical Rippening With Antiprogesterone in Midtrimester Abortions
Cervical Rippening With Antiprogesterone in Midtrimester Abortions
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Abortion, Missed
Drug: Mifepristone
  • Experimental: Pitocin
    Treatment with Pitocin after mifegine
    Intervention: Drug: Mifepristone
  • Active Comparator: Cytotec
    Treatment with cytotec after mifegine
    Intervention: Drug: Mifepristone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
May 2008
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • midtrimester late abortion
  • midtrimester induced abortion

Exclusion Criteria:

  • placenta previa
  • infected abortion
  • rupture of membranes
  • s/p cesarean section *2 or more
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00410345
mifepristoneoxytocin-HMO-CTIL
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Hadassah Medical Organization
Not Provided
Principal Investigator: Assaf Ben-Meir, MD Hadassah Medical Organization
Hadassah Medical Organization
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP