Cervical Rippening With Antiprogesterone in Midtrimester Abortions

NCT ID: NCT00410345

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Abortion, Missed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pitocin

Treatment with Pitocin after mifegine

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

Cytotec

Treatment with cytotec after mifegine

Group Type ACTIVE_COMPARATOR

Mifepristone

Intervention Type DRUG

Interventions

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Mifepristone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* midtrimester late abortion
* midtrimester induced abortion

Exclusion Criteria

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

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Assaf Ben-Meir, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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mifepristoneoxytocin-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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