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

Office Hysteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04044079
• Other study ID #: dinoprostone misoprostol
• Status: Completed
• Phase: Phase 4
• Start date: August 20, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 10, 2020
• Est. primary completion date: January 10, 2020
• 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 or misoprostol therapy (asthma, liver, kidney, or heart disease).

Related Conditions & MeSH terms

• Office Hysteroscopy

Intervention

Drug:
• Dinoprostone
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
• Misoprostol
Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.
• Placebo
one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Locations

Country	Name	City	State
Egypt	Ahmed Samy	Giza

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