Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: a Randomized Controlled Trial

Conditions
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Office Hysteroscopy

Intervention / Treatment
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* Drug: Dinoprostone
* Drug: Misoprostol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dinoprostone<br>1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy. | Drug: Dinoprostone<br>* 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.<br>|
| Active Comparator: misoprostol<br>Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy. | Drug: Misoprostol<br>* Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.<br>|
| Placebo Comparator: placebo<br>one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy. | Drug: Placebo<br>* one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Operative time | From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination | an expected average 10 minutes |