Optimum Misoprostol Dose Prior to Office Hysteroscopy

April 10, 2013 updated by: Waleed El-khayat, Cairo University

The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial

Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • 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, 12211
        • Kasr alainy hospital, faculty of medicine , Cairo university

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patient pre- or postmenopausal undergo office hysteroscopy.
  • Age: from 20 to 60.
  • BMI between 18 and 30.

Exclusion Criteria:

  • PID or
  • Heavy uterine bleeding
  • Cervical malignancy.
  • Symptoms suggestive of endometriosis .
  • Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Misoprostol vaginally, 200 ug
200 ug misoprostol in the posterior vaginal fornix
Drug: Misoprostol
200 ug
Drug: Misoprostol
Misoprostol vaginally, 400 ug
Active Comparator: Misoprostol vaginally, 400ug
Misoprostol in the posterior vaginal fornix
Drug: Misoprostol
200 ug
Drug: Misoprostol
Misoprostol vaginally, 400 ug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 1year
Pain score by VAS
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Easiness
Time Frame: 1year
ease of entry of the office hysteroscopy into the cervix recorded on a 5-point Likert scale: very difficult= 1, difficult = 2, fair = 3, easy = 4, and very easy = 5;
1year
Duration of the procedure
Time Frame: 1year
Duration of hysteroscopy in seconds
1year

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Waleed El-khayat, M.D., Cairo 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

June 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

May 28, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (Estimate)

June 5, 2012

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2752012

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.

Clinical Trials on Infertility

Clinical Trials on Misoprostol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe