Office Hysteroscopy
Conditions
Brief summary
To compare the effectiveness of vaginal dinoprostone and vaginal misoprostol with placebo in minimizing the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.
Detailed description
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes. The most commonly used agent is misoprostol, a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum hemorrhage, and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.
Interventions
DRUGDinoprostone
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
DRUGMisoprostol
Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.
DRUGPlacebo
one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
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 or misoprostol therapy (asthma, liver, kidney, or heart disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | an expected average of 10 minutes | Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity of pain | 30 minutes after the procedure | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10 |
| Operative time | an expected average 10 minutes | From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination |
Countries
Egypt
Outcome results
None listed