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.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Early Pregnancy

Intervention / Treatment
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* Drug: Administration of drugs concomitantly.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Administration of drugs concomitantly. | Drug: Administration of drugs concomitantly.<br>* Administration of oral Mifepristone 600 mg and oral Misoprostol 400 mcg concomitantly.<br>* Other names: no interval;|
| No Intervention: Control<br>Administration of oral Mifepristone 600 mg and after interval of 48 hours administration of oral Misoprostol 400 mcg. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of complete abortion | Success rate of complete abortion without any other surgical intervention | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding amount | Assessment of bleeding amount and duration by the patient (maximum amount of pads per day) and Hemoglobin level before and two weeks after the procedure | two weeks | 
| Self reported pain intensity after two weeks | Visual analogue scale pain severity with scale from 0 to 10, with score 10 representing the maximum level of pain during those two weeks. | two weeks | 
| patient's satisfaction | Post operative women's satisfaction with scale from 0 to 10, with score 10 representing the maximum level of satisfaction. the patient will be asked if she will select this method next time if necessary | two weeks |