- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03397615
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
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 Contact
- Name: Ahmed Maged, MD
- Phone Number: +20201005227404
- Email: dr_ahmedmaged08@kasralainy.edu.eg
Study Contact Backup
- Name: Heba Wagih, MD
- Email: heba.wageih@yahoo.com
Study Locations
-
-
-
Cairo, Egypt, 12151
- Recruiting
- Kasr Alainy medical school
-
Contact:
- Mohamed Nagy, MD
- Email: mnmo75@yahoo.com
-
-
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
16 years to 38 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
|
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
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.
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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