NCT02713074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

March 15, 2016

Last Update Submit

July 16, 2017

Conditions

Postoperative Infection

Outcome Measures

Primary Outcomes (1)

  • rate of postoperative vaginal irritation symptoms

    24 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

povidone-iodine group

Drug: povidone-iodine

Group B

ACTIVE COMPARATOR

Normal saline group

Drug: normal saline

Interventions

povidone-iodineDRUG

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

Group A
normal salineDRUG

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

Group B

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All women who will subject to office Hysterosocpy for gynecological problems

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Interventions

Povidone-IodineSaline Solution

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 18, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)