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.

November 30, 2022 updated by: HaEmek Medical Center, Israel

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Haemek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Administration of drugs concomitantly.
Drug: Administration of drugs concomitantly.
Administration of oral Mifepristone 600 mg and oral Misoprostol 400 mcg concomitantly.
Other Names:
  • no interval
NO_INTERVENTION: Control
Administration of oral Mifepristone 600 mg and after interval of 48 hours administration of oral Misoprostol 400 mcg.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding amount
Time Frame: two weeks
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
Time Frame: 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
Time Frame: two weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2018

Primary Completion (ACTUAL)

December 30, 2021

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 15, 2018

First Posted (ACTUAL)

February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2-17 EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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