Intravaginal Misoprostol Versus Dinoprostone Before Diagnostik Hysteroscopy

August 6, 2012 updated by: Esra Tonguc, Zekai Tahir Burak Women's Health Research and Education Hospital

Comparison of Intravaginal Misoprostol and Dinoprostol for the Purpose of Cervical Ripening Before Diagnostic Hysteroscopy in the Women at the Reproductive Age:RANDOMİSED,CONTROLLED PROSPECTİVE TRİAL

Comparison of intravaginal misoprostol and dinoprostol for the purpose of cervical ripening before diagnostic hysteroscopy in the women at the reproductive age:RANDOMİSED,CONTROLLED PROSPECTİVE TRİAL Objective. Comparison with one another and with control group of vaginal dinoprostol and misoprostol with for the purpose of cervical ripening before diagnostic hysteroscopy.

Population: It was planned for performing to 95 women who appealed to gynecology polyclinic and will be performed diagnostic hysteroscopy.

Methods: Eighty-six women who will be performed diagnostic hysteroscopy assigned as randomize to three groups. It was planned that none procedure will be applied to group 1 for cervical ripening, vaginal misoprostol and vaginal dinoprostone will be practiced to Groups 2 and 3, respectively.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

While diagnostic hysteroscopy allows panoramic view of the uterus cavity, operational hysteroscopy allows to minimal invasive approach in the intrauterine lesions. Most frequently complications of hysteroscopy are cervical rupture, hemorrhage, failure of passage formation and uterus perforation. These generally are related to cervix dilatation's difficulty. These complications can be minimized preoperatively by the cervical ripening.

Present clinic study will be performed on the patients who appealed to gynecology polyclinic of the Konya TRH by the reason of infertility and infertility polyclinic of Zekai Tahir Burak Women Health Education and Research Hospital were planned diagnostic hysteroscopy by intrauterine pathology prediagnosis.Women will be given information about study and written informed consent will be obtained Inclusion criteria: On the HSG,USG or SIS, women at the age of primary or secondary infertile reproductive suspected for intrauterine pathology, no contraindication for hysteroscopy and reproductive age Exclusion criteria: Women are with allergy against to prostaglandins, with diseases in which prostaglandin usage is contraindicated, pregnant, don't given approval, with cervical surgery history and cervical insufficiency.

Post randomization. For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.

After drugs administration, cervical canal will be again evaluated with above mentioned way by bougie before hysteroscopy, patients whose cervixes were easily passed via 5.5 no-hegar bougie, haven't cervical dislocation requirement and then directly hysteroscopy will be applied to them. Other patients will be applied cervical dislocation up to 6 no- hegar bougie before hysteroscopy. These processes also will be applied to patients of the Group 1.

Study Type

Interventional

Enrollment (Anticipated)

30

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 Locations

  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Zekai Tahir Burak Women Health Education Research Hospital
        • Contact:
        • Principal Investigator:
          • Esra Tonguc, M.D.

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 to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • on the HSG,USG or SIS,
  • women at the age of primary or secondary infertile reproductive suspected for intrauterine pathology,
  • no contraindication for hysteroscopy and reproductive age

Exclusion Criteria:

  • women are with allergy against to prostaglandins,
  • with diseases in which prostaglandin usage is contraindicated,
  • pregnant,
  • don't given approval,
  • with cervical surgery history and cervical insufficiency.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dinoprostone and misoprostol

For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.

After drugs administration, cervical canal will be again evaluated with above mentioned way by bougie before hysteroscopy
Drug: misoprostol
Other Names:
  • group 2
Drug: Dinoprostone
Other Names:
  • group 3
Experimental: Misoprostol and control
For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.
Drug: misoprostol
Other Names:
  • group 2
Drug: control
Other Names:
  • group 1
Experimental: dinoprostone and control
For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.
Drug: Dinoprostone
Other Names:
  • group 3
Drug: control
Other Names:
  • group 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
need for cervical dilatation
Time Frame: 2 Months
In the all three groups, patients being necessary cervical dilatation will be determined and their rates will be calculated.
2 Months
Duration of cervical dilatation
Time Frame: 2 Months
In the patients being necessary cervical dilatation, elapsed time for dilatation will be calculated.
2 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of dilatation
Time Frame: 2 Months
For determination of dilatation's ease 5-point Likert scale will be used.
2 Months
Dilatation complications
Time Frame: 2 Months
Cervical ruptures, haemorrhagee, uterine perforation and false passage will be evaluated as complication.
2 Months
Adverse effects
Time Frame: 2 Months
Side effects developing due to drugs in the patients who are in the drug treated- group will be evaluated.
2 Months

Collaborators and Investigators

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

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Publications and helpful links

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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, 2012

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 6, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-31

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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