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Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

Sponsor
Aswan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04500496
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
open label randomized controlled studyopen label randomized controlled study
Masking:
None (Open Label)
Masking Description:
open label randomized controlled study
Primary Purpose:
Prevention
Official Title:
Vaginal Dinoprostone Versus Vaginal Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: a Randomized Controlled Trial
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
Jan 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: INH

3 tablet of INH 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.

Drug: INH
3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy
Other Names:
  • Isonicotinic acid hydrazide

    		•
    Active Comparator: dinoprostone

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

    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.
    Other Names:
  • prostin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Operative time [15 minutes]

      From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aswan University Hospital Aswan Egypt 81528

    Sponsors and Collaborators

    • Aswan University Hospital

    Investigators

    • Study Chair: nahla w Shady, md, Aswan universirty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    hany farouk, A Professor, Aswan University Hospital
    ClinicalTrials.gov Identifier:
    NCT04500496
    Other Study ID Numbers:
    • aswu/351/4/19
    First Posted:
    Aug 5, 2020
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Isoniazid
    Dinoprostone

    Study Results

    No Results Posted as of Sep 29, 2021