Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients

NCT ID: NCT04044079

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2020-02-10

Brief Summary

To compare the effectiveness of vaginal dinoprostone and vaginal misoprostol with placebo 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. The most commonly used agent is misoprostol, a synthetic prostaglandin E1 (PGE1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum hemorrhage, and cervical ripening. In contrast, dinoprostone, a natural PGE2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Conditions

Office Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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: EXPERIMENTAL

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.

misoprostol

Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.

placebo

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Interventions

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

Misoprostol

Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.

Intervention Type: DRUG

Placebo

one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

Intervention Type: DRUG

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 misoprostol therapy (asthma, liver, kidney, or heart disease).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Ahmed Samy

Giza, , Egypt

Countries

Egypt

Other Identifiers

dinoprostone misoprostol

Identifier Type: -

Identifier Source: org_study_id