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NCT02713074 Clinical Trial

Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy

Postoperative Infection Clinical Trial

— PISOH  

Official title:
A Comparison Between Povidone-iodine and Normal Saline in Vaginal Cleansing Before Office Hysterosocpy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02713074
Other study ID # PI-S
Secondary ID
Status Completed
Phase Phase 3
First received March 15, 2016
Last updated July 16, 2017
Start date October 2016
Est. completion date July 2017

Study information
Verified date July 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 147
Est. completion date July 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• povidone-iodine
The patients will be subjected to povidone-iodine (Betadine7.5%) for vaginal cleaning before office hysteroscopy
• normal saline
The patients will be subjected to normal saline (Sod. Chloride 0.9%, Nile) for vaginal cleaning

Locations
Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary rate of postoperative vaginal irritation symptoms 24 hours
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