Misoprostol Prior to Office Hysteroscopy in Patients With no Risk Factors for Experiencing Unacceptable Pain

Phase 2

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Misoprostol

• Registration Number: NCT02318225
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Detailed Description

Cervical ripening with misoprostol to minimize the pain experienced during office hysteroscopy has been proposed by several authors.

The use of misoprostol is usually associated with undesired side effects and therefore any beneficial effect of misoprostol on reducing pain should be weighed against its undesired side effects (nausea, vomiting, diarrhea, fever, shivering, pain) and coasts. Till now , no studies have yet determined whether misoprostol should be used routinely or for the subgroup of patients at higher risk for cervical stenosis.

The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-17
• Study Start: 2015-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-19
• Last Update Posted: 2015-09-22
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patients with at least one vaginal delivery who have an indication for office hysteroscopy.

Exclusion Criteria

• Nulliparous patients, menopausal patients and patients with cervical pathology, and previous history of caesarean section or cervical surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo is administered vaginally 12 hours before office hysteroscopy
Misoprostol	Misoprostol	Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy

Primary Outcome Measures

Name	Time	Method
Intensity of pain	procedure

Secondary Outcome Measures

Name	Time	Method
Operative time	procedure

Trial Locations

Locations (1)

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