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

Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Office Hysteroscopy
• Intervention / Treatment: Drug: Dinoprostone; Drug: Misoprostol; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 11231
    • Ahmed Samy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Active Comparator: misoprostol; Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.	Drug: Misoprostol; Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.
Placebo Comparator: placebo; one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.	Drug: Placebo; one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10	an expected average of 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of pain	Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10	30 minutes after the procedure
Operative time	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination	an expected average 10 minutes

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): February 10, 2020

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 29, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Dinoprostone
• Other Study ID Numbers: dinoprostone misoprostol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No