Cervical Rippening With Antiprogesterone in Midtrimester Abortions - Full Text View

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

Drug Information available for: Mifepristone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410345

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Assaf Ben-Meir, MD

Hadassah Medical Organization, Jerusalem, Israel

More Information

No publications provided

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

Study placed in the following topic categories:

Pregnancy Complications
Abortion, Missed
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists

Contraceptive Agents, Female
Mifepristone
Abortion, Spontaneous
Contraceptives, Postcoital
Hormones

Additional relevant MeSH terms:

Abortifacient Agents, Steroidal
Contraceptives, Postcoital, Synthetic
Pregnancy Complications
Abortion, Missed
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female

Mifepristone
Reproductive Control Agents
Luteolytic Agents
Contraceptives, Postcoital
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Menstruation-Inducing Agents
Contraceptives, Oral, Synthetic
Abortion, Spontaneous

ClinicalTrials.gov processed this record on May 06, 2009