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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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cervical Rippening With Antiprogesterone in Midtrimester Abortions

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

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

Enrollment: 145
Study Start Date: August 2004
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pitocin
Treatment with Pitocin after mifegine
Drug: Mifepristone
Active Comparator: Cytotec
Treatment with cytotec after mifegine
Drug: Mifepristone

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410345


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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
First Submitted: December 11, 2006
First Posted: December 12, 2006
Last Update Posted: March 1, 2017
Last Verified: May 2008

Additional relevant MeSH terms:
Abortion, Missed
Abortion, Spontaneous
Pregnancy Complications
Mifepristone
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents