Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy

NCT ID: NCT02713074

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

povidone-iodine group

Group Type ACTIVE_COMPARATOR

povidone-iodine

Intervention Type DRUG

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

Group B

Normal saline group

Group Type ACTIVE_COMPARATOR

normal saline

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

povidone-iodine

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

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Mohamed Abbas

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI-S

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.