Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

Office Hysteroscopy Clinical Trial

Official title:

Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: A Randomized Double-Blind Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683914
• Other study ID #: vaginal dinoprostone
• Status: Completed
• Phase: Phase 4
• Start date: September 30, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 28, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Menopausal patients with an indication for of?ce hysteroscopy (postmenopausal bleeding or abnormal ultrasound ?ndings)

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).

Related Conditions & MeSH terms

• Office Hysteroscopy

Intervention

Drug:
• 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 diagnostic hysteroscopy.
• placebo vaginal tablet
1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Operative time	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination	an expected average 10 minutes