MedTrace Logo

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

NCT02328495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-07-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Misoprostol

Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic. Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).

OTHER

Bladder Filling

Patients in bladder filling group will be instructed to drink one liter of water and to avoid urination during the one and half hour period before office hysteroscopy procedure..A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach . All the procedures will be diagnostic. Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Usama M Fouda, M.D,PhD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02328495 on ClinicalTrials.gov