Hysteroscopy
Conditions
Brief summary
To compare the effectiveness of vaginal dinoprostone with placebo in minimizing the pain experienced by primarily infertile 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 haemorrhage, 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
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled 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
15 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup
Exclusion criteria
* • women with suspected pregnancy * heavy vaginal bleeding * recent pelvic infection * those known to have hypersensitivity or contraindication to dinoprostone * those who received analgesics prior to OH * a concomitant neurologic disease that could affect the correct evaluation of pain
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 |
Contacts
Primary ContactAHMED SAMY, MD
Outcome results
None listed