Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion

NCT ID: NCT03044093

Last Updated: 2017-02-06

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-01-31

Brief Summary

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Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial

Detailed Description

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Conditions

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Second Trimester Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MISOPROSTOL alone

the common practice currently in our medical center for second trimester medical abortion/ Placebo

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

The group that will only get Misoprostol

Misoprostol

Intervention Type DRUG

Both groups will get think drug

Mifepristone and Misoprostol

in addition to the common practice currently in our medical center for second trimester medical abortion we will add Mifepristone before administering Misoprostol.

Mifepristone

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

The group that will get in addition to Misoprostol also Mifepristone

Misoprostol

Intervention Type DRUG

Both groups will get think drug

Interventions

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Mifepristone

The group that will get in addition to Misoprostol also Mifepristone

Intervention Type DRUG

Placebo

The group that will only get Misoprostol

Intervention Type DRUG

Misoprostol

Both groups will get think drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* healthy
* no allergy known to these drugs
* second trimester abortion

Exclusion Criteria

* hematology diseases
* clotting factor deficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rambam Medical Campus

Haifa, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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MEIR NIZRI, MD

Role: CONTACT

972-50-2061521

Facility Contacts

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MEIR NIZRI, MD

Role: primary

Other Identifiers

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0299-16-RMB

Identifier Type: -

Identifier Source: org_study_id

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