Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

Postmenopausal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04500496
• Other study ID #: aswu/351/4/19
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: September 2021
• Source: Aswan University Hospital
• Contact: hany f Sallam, md
• Phone: +20102435461
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effectiveness of vaginal dinoprostone and vaginal Isonicotinic acid hydrazide 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 60 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 INH therapy

Related Conditions & MeSH terms

• Postmenopausal Bleeding

Intervention

Drug:
• INH
3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy
• dinoprostone
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

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	10 minutes
Secondary	Operative time	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination	15 minutes
Secondary	Pain intensity will be assessed by visual analogue scale	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