Misoprostol for Cervical Priming Before Office Hysteroscopy
NCT ID: NCT03276000
Last Updated: 2017-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
100 participants
INTERVENTIONAL
2017-10-01
2018-03-01
Brief Summary
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Detailed Description
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However, the study population consists of 100 patients in reproductive age that requires diagnostic hysteroscopy for investigation of infertility or AUB.
The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018.
The Patients will be allocated equally into 2 groups ( each group contain 50 patients)
Groups will be as follows:
1. Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before the procedure.
2. Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the procedure moistened with saline solution will be inserted in posterior fornix of vagina.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Group A
50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy
office hysteroscopy
A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.
group B
50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy moistened with saline solution will be inserted in posterior fornix of vagina.
office hysteroscopy
A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.
Interventions
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office hysteroscopy
A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.
Eligibility Criteria
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Inclusion Criteria
2. Reproductive age \>19 - 45yrs.
3. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)
Exclusion Criteria
1. Cardiovascular disease
2. Severe bronchial asthma.
3. Hypertension.
4. Renal failure.
5. Known sensitivity to Prostaglandins
Contraindication to office hysteroscopy such as:-
1. Pelvic inflammatory disease.
2. Marked cervical stenosis.
3. Known cervical malignancy.
4. pregnancy
5. profuse uterine bleeding
6. Recent uterine perforation.
Neurological disorders affecting the evaluation of pain.
Previous cervical surgery.
19 Years
45 Years
FEMALE
No
Sponsors
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Kasr El Aini Hospital
OTHER
Responsible Party
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sarah mohamed hassan
lecturer of obstetrics and gynecology Cairo university
Locations
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Kasr El Ainiy Hospital
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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sarah M Hassan, Lecturer
Role: primary
References
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Sordia-Hernandez LH, Rosales-Tristan E, Vazquez-Mendez J, Merino M, Iglesias JL, Garza-Leal JG, Morales A. Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients. Fertil Steril. 2011 Feb;95(2):759-61. doi: 10.1016/j.fertnstert.2010.07.1066. Epub 2010 Aug 21.
Bastu E, Celik C, Nehir A, Dogan M, Yuksel B, Ergun B. Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. Int Surg. 2013 Apr-Jun;98(2):140-4. doi: 10.9738/INTSURG-D-12-00024.1.
El-Mazny A, Abou-Salem N. A double-blind randomized controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy. Fertil Steril. 2011 Oct;96(4):962-5. doi: 10.1016/j.fertnstert.2011.04.049. Epub 2011 May 14.
Other Identifiers
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12345
Identifier Type: -
Identifier Source: org_study_id