Same-day Cervical Preparation With Misoprostol Before Hysteroscopy

April 28, 2016 updated by: Hadas Ganer Herman, Wolfson Medical Center

Same-day Cervical Preparation With Misoprostol Before Hysteroscopy: a Randomized Trial of Different Routes of Administration

This is a randomized trial, assessing Misoprostol efficacy in cervical preparation several hours prior to hysteroscopy, comparing the different routes of administration (PO/PV/buccal). Initial cervical dilatation will be assessed, as well as surgical ease of dilatation, time required to achieve dilatation and patient preference.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Israel
      • Holon, Israel
        • Recruiting
        • Edith Wolfson Medical Center
        • Contact:

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients admitted for elective hysteroscopy (diagnostic/surgical) at Wolfson Medical Center
  • Written consent supplied

Exclusion Criteria:

  • Contraindications to prostaglandin treatment (severe asthma, glaucoma, severe cardiac disease, renal failure)
  • Prostaglandin allergy
  • Pregnancy
  • Genital infection
  • Space-occupying lesion in the endocervical canal
  • Prior cervical surgery

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PO Misoprostol
Patients assigned to PO Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Drug: Misoprostol (Cytotec)
Active Comparator: PV Misoprostol
Patients assigned to PV Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Drug: Misoprostol (Cytotec)
Active Comparator: Buccal Misoprostol
Patients assigned to buccal Misoprostol (Cytotec) 400 mg once, 2-4 hours prior to hysteroscopy
Drug: Misoprostol (Cytotec)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative cervical width in centimeters
Time Frame: intraoperative
Initial cervical dilatation assessed by performing cervical dilatation , beginning with a number 10 Hegar dilator and subsequently inserting smaller Hegar dilators until the dilator can pass through the internal os without resistance. The largest one to pass will consist the initial cervical width.
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to achieve cervical dilatation
Time Frame: intraoperative
The time in minutes required for dilatation up to a number 10 Hegar
intraoperative
Ease of cervical dilatation
Time Frame: intraoperative
The subjective ease of cervical dilatation recorded by the surgeon on a 5-point Likert scale (1-very difficult, 5- very easy)
intraoperative
Patient preference
Time Frame: baseline
Patient acceptability of the administration of medication on a 5-point Likert scale (1-very uncomfortable, 5-very comfortable)
baseline
Adverse effects of medication
Time Frame: baseline
Self reported misoprostol-associated adverse effects before the procedure (such as nausea, vomiting)
baseline
Surgical complications
Time Frame: intraoperative
Complications arising during surgery (perforation, cervical laceration, excess bleeding)
intraoperative

Collaborators and Investigators

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

Sponsor

Wolfson Medical Center

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

July 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 14, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 17, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0083-15-WOMC

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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