Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy

Phase 2

Completed

• Conditions: Pain
• Interventions: Other: Bladder Filling; Drug: Misoprostol

• Registration Number: NCT02328495
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Detailed Description

Several studies revealed that cervical ripening with misoprostol is effective in reducing pain especially in postmenopausal patients. A recent randomized controlled trial revealed that uterine striating by bladder filling prior to office hysteroscopy is associated with reduced pain perception and easier introduction of hysteroscope through the cervix.

The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.

Study Timeline

• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2014-12-31
• Study Start: 2015-01
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-26
• Last Update Posted: 2016-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• Menopausal patients who have an indication for office hysteroscopy

Exclusion Criteria

• Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bladder Filling	Bladder Filling	Uterine straightening by bladder filling before office hysteroscopy
Misoprostol	Misoprostol	Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy

Primary Outcome Measures

Name	Time	Method
Intensity of pain [ visual analogue scale ranging from 0 to 10 ]	Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 10 minutes] and 30 minutes after the procedure

Secondary Outcome Measures

Name	Time	Method
Operative time	From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination[ an expected average 10 minutes]

Trial Locations

Locations (1)

Obstetrics and Gynecology Department,Cairo university; 🇪🇬 Cairo, Egypt