Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Intensity of pain
Study Overview
Brief Summary
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.
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) analogue that is frequently administered in off-label use in obstetrics and gynaecology 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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 therapy (asthma, liver, kidney, or heart disease).
Arms & Interventions
dinoprostone arm
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
Intervention: Dinoprostone 3Mg Vaginal Tablet (Drug)
placebo
one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
Intervention: placebo vaginal tablet (Drug)
Outcomes
Primary Outcomes
Intensity of pain
Time Frame: 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 Outcomes
- Intensity of pain(30 minutes after the procedure)
- Operative time(an expected average 10 minutes)
Investigators
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University