Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

Phase 4

Completed

• Conditions: Office Hysteroscopy
• Interventions: Drug: Dinoprostone 3Mg Vaginal Tablet; Drug: placebo vaginal tablet

• Registration Number: NCT03683914
• Lead Sponsor: Cairo University

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 Timeline

• Study First Submitted: 2018-09-22
• Study First Submitted QC: 2018-09-22
• Study First Posted: 2018-09-25
• Study Start: 2018-09-30
• Primary Completion: 2019-01-30
• Study Completion: 2019-02-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-22
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

• Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dinoprostone arm	Dinoprostone 3Mg Vaginal Tablet	1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
placebo	placebo vaginal tablet	one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Medicine Cairo University; 🇪🇬 Cairo, Egypt