Intravaginal Misoprostol Versus Dinoprostone Before Diagnostik Hysteroscopy

Zekai Tahir Burak Women's Health Research and Education Hospital

Status and phase: Unknown; Phase 4

Conditions: Cervical Ripening

Treatments: Drug: control; Drug: Dinoprostone; Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01620814

2012-31

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Dinoprostone and misoprostol

Experimental group

Description:

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

Treatment:

Drug: misoprostol

Drug: Dinoprostone

Misoprostol and control

Experimental group

Description:

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.

Treatment:

Drug: misoprostol

Drug: control

dinoprostone and control

Experimental group

Description:

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.

Treatment:

Drug: Dinoprostone

Drug: control