Overview

This trial is active, not recruiting.

Condition postoperative infection
Treatments povidone-iodine, normal saline
Phase phase 3
Sponsor Assiut University
Start date March 2016
End date August 2016
Trial size 100 participants
Trial identifier NCT02713074, PI-S

Summary

The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Active Comparator)
povidone-iodine group
povidone-iodine
The patients will be subjected to povidone-iodine (Betadine7.5%, phama Care) for vaginal cleaning before office hysteroscopy
(Active Comparator)
Normal saline group
normal saline
The patients will be subjected to normal saline (Sod. Chloride 0.9%, Nile) for vaginal cleaning

Primary Outcomes

Measure
degree of fever
time frame: 24 hours

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: 1 - All women who will subject to office Hysterosocpy for gynecological problems Exclusion Criteria: 1. All patients have current vaginitis or urinary tract infection before the Hysteroscopy 2. Diabetic women. 3. Women with body mass index > 25 kg/m2.

Additional Information

Official title A Comparison Between Povidone-iodine and Normal Saline in Vaginal Cleansing Before Office Hysterosocpy: a Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Assiut University.