Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy

Aswan University Hospital

Status: Unknown

Conditions: Postmenopausal Bleeding

Treatments: Drug: dinoprostone; Drug: INH

Study type: Interventional

Funder types: Other

Identifiers

NCT04500496

aswu/351/4/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

INH

Experimental group

Description:

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

Treatment:

Drug: INH

dinoprostone

Active Comparator group

Description:

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

Treatment:

Drug: dinoprostone