Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion.

Early Pregnancy Clinical Trial

Official title:
Comparison of the Effectiveness of Treatment With Mifepristone and Misoprostol at the Same Time Compared to the Administration of Drugs at a 48-hour Interval for Medical Abortion in Young Pregnancy - A Prospective Randomized Controlled Trial.

Status Active, not recruiting

Clinical Trial Summary

Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. There is little data to compare the efficacy of concomitant administration of both drugs and different time intervals. This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs.

Clinical Trial Description

Medical termination of pregnancy is a common and safe alternative to surgical termination of pregnancy(8). According to the original protocol ,the administration of oral Mifepristone 600 mg is followed by oral Misoprostol 400 mcg in an interval of 36 to 48 hours. Shortening this time interval may convince patients to avoid surgical termination of pregnancy, enhance patient's compliance to treatment and even be more economically. The current protocol in the investigators unit includes oral administration of Mifepristone 600 mg and oral Misoprostol 400 mcg in a time interval of 48 hours. The patients are recommended to have an ultrasound examination after 2 to 3 weeks. There is little data to compare the efficacy of concomitant administration of both drugs according to the dosage of this protocol and different time intervals. This study evaluates the success rate and side effects of medical termination of pregnancy while both drugs are administrated concomitantly in comparison to interval of 48 hours between the drugs. Participants in the study group will be given both drugs at the same time while participants in the control group will be given Mifepristone and Misoprostol in an interval of 48 hours. The investigators hypothesis is that administration of both drugs concomitantly will not change significantly the success rate of the procedure and will not enhance the side effects. ;

Study Design

Related Conditions & MeSH terms

Early Pregnancy

Clinical Trial Details

NCT number	NCT03440866
Study type	Interventional
Source	HaEmek Medical Center, Israel
Contact
Status	Active, not recruiting
Phase	N/A
Start date	March 1, 2018
Completion date	December 30, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.