Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

Not Applicable

• Conditions: Postmenopausal Bleeding
• Interventions: Drug: INH; Drug: dinoprostone

• Registration Number: NCT04500496
• Lead Sponsor: Aswan University Hospital

Brief 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.

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.

Study Timeline

• Study First Submitted: 2020-08-03
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Study Start: 2020-09-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29
• Primary Completion: 2021-12-30
• Study Completion: 2022-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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 INH therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INH	INH	3 tablet of INH 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
dinoprostone	dinoprostone	1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Intensity of pain	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
Operative time	15 minutes	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination
Pain intensity will be assessed by visual analogue scale	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

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt