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.

HaEmek Medical Center, Israel

Status: Active, not recruiting

Conditions: Early Pregnancy

Treatments: Drug: Administration of drugs concomitantly.

Study type: Interventional

Funder types: Other

Identifiers

NCT03440866

2-17 EMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• intrauterine singleton pregnancy of less than 49 days, reassured by ultrasound examination
• patient who desire to terminate their pregnancy and have approval of the committee for termination of pregnancy
• patient who gave their consent to have a surgical abortion eventual if needed

Exclusion criteria

• contraindication to Mifepristone or Misoprostol
• suspected ectopic pregnancy
• systemic treatment with steroids
• adrenal insufficiency
• heart and blood vessels disease
• coagulopathy or use of anti-thrombotic agents
• uncontrolled asthma
• liver or kidney insufficiency
• anorexia
• intrauterine device
• breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Intervention

Experimental group

Description:

Administration of drugs concomitantly.

Treatment:

Drug: Administration of drugs concomitantly.

Control

No Intervention group

Description:

Administration of oral Mifepristone 600 mg and after interval of 48 hours administration of oral Misoprostol 400 mcg.