Povidone-iodine Versus Saline in Vaginal Cleansing Before... | NCT02713074

Studies
Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy

NCT02713074

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jul 19, 2017Actual

Enrollment

147Actual

Phase

Phase 3

Conditions

Postoperative Infection

Interventions

povidone-iodine
normal saline

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Mar 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Mar 15, 2016

First Submission Date that Met QC Criteria

Mar 15, 2016

First Posted Date

Mar 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2017

Last Update Posted Date

Jul 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

147Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator	povidone-iodine group	Drug: povidone-iodine
Group B	Active Comparator	Normal saline group	Drug: normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
povidone-iodine	Drug	The patients will be subjected to povidone-iodine (Betadine7.5%) for vaginal cleaning before office hysteroscopy	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
rate of postoperative vaginal irritation symptoms		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011206	Povidone-Iodine
D000077330	Saline Solution

Ancestor Terms

ID	Term
D007466	Iodophors
D017613	Iodine Compounds
D007287	Inorganic Chemicals
D011145	Polyvinyls

Browse Leaves

Not provided

Browse Branches

Not provided