Medical Abortion With Single Daily Dose of Misoprostol

January 26, 2019 updated by: Mohamed S Sweed, MD, Ain Shams University

Medical Abortion With Multiple vs Single Daily Dose of Misoprostol in First Trimester Miscarriage: A Randomized Clinical Trial.

Medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

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

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Maternity Hospital

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 to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Maternal age more than 18 years old (age of legal consent).
  • Gestational age less than 13 weeks.
  • Hemoglobin >10 g/dL.
  • BMI between 25 kg/m2 and 35 kg/m2.
  • Missed abortion.
  • Living fetus with multiple congenital malformations incompatible with life.

Exclusion Criteria:

  • Maternal age less than 18 years old.
  • Gestational age more than 12 weeks.
  • Hemoglobin <10 g/dL.
  • Anencephaly.
  • Fibroid uterus.
  • BMI less than 25kg/m2 and more than 35kg/m2.
  • Coagulopathy.
  • History or evidence of adrenal pathology.
  • Previous attempts for induction of abortion in the current pregnancy.
  • Allergy to misoprostol or letrozole.
  • Medical disorder that contraindicate induction of abortion (e.g. heart failure).

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Single daily dose
Drug: Misoprostol
Misoprostol
Active Comparator: Multiple daily doses
Drug: Misoprostol
Misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete miscarriage
Time Frame: one week
Assessed by trans-vaginal ultrasound where endometrial thickness less than 15 mm is considered complete miscarriage
one week

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

April 1, 2018

Primary Completion (Actual)

January 10, 2019

Study Completion (Actual)

January 10, 2019

Study Registration Dates

First Submitted

March 25, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (Actual)

April 4, 2018

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 26, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1753

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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