Intravaginal Misoprostol Versus Dinoprostone Before Diagnostik Hysteroscopy

Cervical Ripening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01620814
• Other study ID #: 2012-31
• Status: Recruiting
• Phase: Phase 4
• First received: June 7, 2012
• Last updated: August 6, 2012
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: August 2012
• Source: Zekai Tahir Burak Women's Health Research and Education Hospital
• Contact: Esra Tonguc, M.D.
• Phone: 053241414889
• Email: esratonguc[@]yahoo.com
• Is FDA regulated: No
• Health authority: Zekai Tahir Burak Women Health Education and Resarch Hospital:TURKEY
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening

Intervention

Drug:
• Dinoprostone

• misoprostol

• control

Locations

Country	Name	City	State
Turkey	Zekai Tahir Burak Women Health Education Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Zekai Tahir Burak Women's Health Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	need for cervical dilatation	In the all three groups, patients being necessary cervical dilatation will be determined and their rates will be calculated.	2 Months	Yes
Primary	Duration of cervical dilatation	In the patients being necessary cervical dilatation, elapsed time for dilatation will be calculated.	2 Months	Yes
Secondary	Ease of dilatation	For determination of dilatation's ease 5-point Likert scale will be used.	2 Months	Yes
Secondary	Dilatation complications	Cervical ruptures, haemorrhagee, uterine perforation and false passage will be evaluated as complication.	2 Months	Yes
Secondary	Adverse effects	Side effects developing due to drugs in the patients who are in the drug treated- group will be evaluated.	2 Months	Yes