Intravaginal Misoprostol Versus Dinoprostone Before Diagnostik Hysteroscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Esra Tonguc, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01620814
First received: June 7, 2012
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Cervical Ripening
Drug: Dinoprostone
Drug: misoprostol
Drug: control
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Zekai Tahir Burak Women's Health Research and Education Hospital:

Primary Outcome Measures:
  • need for cervical dilatation [ Time Frame: 2 Months ] [ Designated as safety issue: Yes ]
    In the all three groups, patients being necessary cervical dilatation will be determined and their rates will be calculated.

  • Duration of cervical dilatation [ Time Frame: 2 Months ] [ Designated as safety issue: Yes ]
    In the patients being necessary cervical dilatation, elapsed time for dilatation will be calculated.


Secondary Outcome Measures:
  • Ease of dilatation [ Time Frame: 2 Months ] [ Designated as safety issue: Yes ]
    For determination of dilatation's ease 5-point Likert scale will be used.

  • Dilatation complications [ Time Frame: 2 Months ] [ Designated as safety issue: Yes ]
    Cervical ruptures, haemorrhagee, uterine perforation and false passage will be evaluated as complication.

  • Adverse effects [ Time Frame: 2 Months ] [ Designated as safety issue: Yes ]
    Side effects developing due to drugs in the patients who are in the drug treated- group will be evaluated.


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Dinoprostone
Other Name: group 3
Drug: misoprostol
Other Name: group 2
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 Name: group 2
Drug: control
Other Name: 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 Name: group 3
Drug: control
Other Name: group 1

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620814

Contacts
Contact: Esra Tonguc, M.D. 053241414889 esratonguc@yahoo.com

Locations
Turkey
Zekai Tahir Burak Women Health Education Research Hospital Recruiting
Ankara, Turkey
Contact: Turgut Var, M.D.    05323719862    drturgtvar@yahoo.com   
Principal Investigator: Esra Tonguc, M.D.         
Sponsors and Collaborators
Zekai Tahir Burak Women's Health Research and Education Hospital
  More Information

No publications provided

Responsible Party: Esra Tonguc, Assoc.Prof, Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier: NCT01620814     History of Changes
Other Study ID Numbers: 2012-31
Study First Received: June 7, 2012
Last Updated: August 6, 2012
Health Authority: Zekai Tahir Burak Women Health Education and Resarch Hospital:TURKEY

Keywords provided by Zekai Tahir Burak Women's Health Research and Education Hospital:
misoprostol
dinoprostone
cervical ripening
diagnostic hysteroscopy

Additional relevant MeSH terms:
Dinoprostone
Misoprostol
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014