Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-27 @ 6:47 AM
Study NCT ID:
NCT03440866
Status:
UNKNOWN
Last Update Posted:
2022-12-01
First Post:
2018-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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.
Sponsor:
HaEmek Medical Center, Israel
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: