Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

NCT04500496 | Unknown DMC

• 1 other identifier: aswu/351/4/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Operative time

  15 minutes

• Pain intensity will be assessed by visual analogue scale

  30 minutes after the procedure

Study Arms (2)

INH

EXPERIMENTAL

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

Drug: INH

dinoprostone

ACTIVE COMPARATOR

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

Interventions

INH DRUG

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

Also known as: Isonicotinic acid hydrazide

INH

dinoprostone DRUG

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

Also known as: prostin

dinoprostone

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Menopausal patients with an indication for office hysteroscopy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Interventions

Isoniazid; Dinoprostone; KLK15 protein, human

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• nahla w Shady, md

  Aswan universirty

  STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461; hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052; hanygyne@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label randomized controlled study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: open label randomized controlled study

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 5, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: January 30, 2022
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)