Office Hysteroscopy Clinical Trial
Official title:
Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial
Verified date | March 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the effectiveness of vaginal dinoprostone with placebo in minimising the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.
Status | Completed |
Enrollment | 102 |
Est. completion date | February 28, 2019 |
Est. primary completion date | January 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Menopausal patients with an indication for of?ce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ?ndings) Exclusion Criteria: - • Nulliparous patients - patients with cervical pathology - retroverted uterus (detected by transvaginal ultrasound) - previous cervical surgery - patients with severe vaginal bleeding - allergy or contraindications to dinoprostone therapy (asthma, liver, kidney, or heart disease). |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intensity of pain | Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10 | an expected average of 10 minutes | |
Secondary | Intensity of pain | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10 | 30 minutes after the procedure | |
Secondary | Operative time | From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination | an expected average 10 minutes |
Status | Clinical Trial | Phase | |
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Completed |
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