Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections

July 24, 2019 updated by: Ahmed M Maged, MD, Cairo University

Effect of Vaginal Douching With Betadine Versus Non Douching Before CS for Prevention of Post Operative Infections

The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Recruiting
        • Kasr Alainy medical school
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any patient undergoing CS

Exclusion Criteria:

  • • Betadine allegy.

    • Rupture membranes.
    • Accidental Hemorrhage.
    • H/O suggestive chorioamnionitis ; uterine tenderness, offensive vaginal discharge, fever medical disorders as diabetes, hypertension , cardiac or renal diseqases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Betadine douches
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
Behavioral: Betadine douches
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
No Intervention: Non betadine douches
subjects didnot received a vaginal preparation prior to caesarean delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum endometritis
Time Frame: 6 weeks after Cesarean section
a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy.
6 weeks after Cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative wound infection
Time Frame: 6 weeks after Cesarean section
erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy
6 weeks after Cesarean section
Postoperative fever
Time Frame: 3 weeks after Cesarean section
temperature higher than 38 degrees C
3 weeks after Cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2019

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 6, 2018

First Submitted That Met QC Criteria

January 6, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

July 26, 2019

Last Update Submitted That Met QC Criteria

July 24, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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