Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

NCT ID: NCT04500496

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-01-30

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.

Conditions

Postmenopausal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

INH

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

Group Type: EXPERIMENTAL

INH

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

dinoprostone

Intervention Type: DRUG

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

Interventions

INH

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Isonicotinic acid hydrazide; prostin

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

A Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

Aswan University Hospital

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hany f Sallam, md

Role: CONTACT

hany.farouk@aswu.edu.eg

+20102435461 ext. 002

nahla w Shady, md

Role: CONTACT

hanygyne@yahoo.com

+201022336052 ext. 002

Facility Contacts

Hany F Sallam, MD

Role: primary

hany.farouk@aswu.edu.eg

0122336052 ext. 002

Nahla W Shady, MD

Role: backup

nahla.elsayed@aswu.edu.eg

01092440504 ext. 002

Other Identifiers

aswu/351/4/19

Identifier Type: -

Identifier Source: org_study_id