PISOH: Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02713074

Collaborator

(none)

147

Enrollment

Location

Arms

Actual Duration (Months)

16.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Infection	Drug: povidone-iodine Drug: normal saline	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

147 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A povidone-iodine group	Drug: povidone-iodine The patients will be subjected to povidone-iodine (Betadine7.5%) for vaginal cleaning before office hysteroscopy
Active Comparator: Group B Normal saline group	Drug: normal saline The patients will be subjected to normal saline (Sod. Chloride 0.9%, Nile) for vaginal cleaning

Arm

Intervention/Treatment

Active Comparator: Group A

povidone-iodine group

Drug: povidone-iodine

The patients will be subjected to povidone-iodine (Betadine7.5%) for vaginal cleaning before office hysteroscopy

Active Comparator: Group B

Normal saline group

Drug: normal saline

The patients will be subjected to normal saline (Sod. Chloride 0.9%, Nile) for vaginal cleaning

Outcome Measures

Primary Outcome Measures

rate of postoperative vaginal irritation symptoms [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

1 - All women who will subject to office Hysterosocpy for gynecological problems

Exclusion Criteria:

All patients have current vaginitis or urinary tract infection before the hysteroscopy
Diabetic women.
Women with body mass index > 25 kg/m2.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT02713074

Other Study ID Numbers:

PI-S

First Posted:

Mar 18, 2016

Last Update Posted:

Jul 19, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Povidone-Iodine

Povidone

Study Results

No Results Posted as of Jul 19, 2017