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Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion

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.
 
ClinicalTrials.gov Identifier: NCT03044093
Recruitment Status : Unknown
Verified February 2017 by Rambam Health Care Campus.
Recruitment status was:  Recruiting
First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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

Condition or disease Intervention/treatment Phase
Second Trimester Abortion Drug: Mifepristone Drug: Placebo Drug: Misoprostol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MISOPROSTOL alone
the common practice currently in our medical center for second trimester medical abortion/ Placebo
Drug: Placebo
The group that will only get Misoprostol

Drug: Misoprostol
Both groups will get think drug

Experimental: 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

Drug: Mifepristone
The group that will get in addition to Misoprostol also Mifepristone

Drug: Misoprostol
Both groups will get think drug




Primary Outcome Measures :
  1. Reduction in Hospital Stay Duration [ Time Frame: Up to 24 months ]
    number of days of hospital stay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • hematology diseases
  • clotting factor deficiency

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): NCT03044093


Contacts
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Contact: MEIR NIZRI, MD 972-50-2061521

Locations
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Israel
Rambam Medical Campus Recruiting
Haifa, Israel
Contact: MEIR NIZRI, MD         
Sponsors and Collaborators
Rambam Health Care Campus

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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03044093    
Other Study ID Numbers: 0299-16-RMB
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: February 6, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
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