Back to resultsEffect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections
Primary Purpose
Puerperal Infection
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Betadine douches
Sponsored by
About this trial
This is an interventional prevention trial for Puerperal Infection
Eligibility Criteria
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
Sites / Locations
- Kasr Alainy medical schoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Betadine douches
Non betadine douches
Arm Description
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
subjects didnot received a vaginal preparation prior to caesarean delivery
Outcomes
Primary Outcome Measures
Postpartum endometritis
a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy.
Secondary Outcome Measures
Postoperative wound infection
erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy
Postoperative fever
temperature higher than 38 degrees C
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03397615
Brief Title
Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections
Official Title
Effect of Vaginal Douching With Betadine Versus Non Douching Before CS for Prevention of Post Operative Infections
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Puerperal Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Betadine douches
Arm Type
Active Comparator
Arm Description
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
Arm Title
Non betadine douches
Arm Type
No Intervention
Arm Description
subjects didnot received a vaginal preparation prior to caesarean delivery
Intervention Type
Behavioral
Intervention Name(s)
Betadine douches
Intervention Description
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
Primary Outcome Measure Information:
Title
Postpartum endometritis
Description
a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy.
Time Frame
6 weeks after Cesarean section
Secondary Outcome Measure Information:
Title
Postoperative wound infection
Description
erythema, tenderness, prurulent drainage from the incision site, with or without fever, requiring antibiotic therapy
Time Frame
6 weeks after Cesarean section
Title
Postoperative fever
Description
temperature higher than 38 degrees C
Time Frame
3 weeks after Cesarean section
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed maged, MD
Phone
+20201005227404
Email
dr_ahmedmaged08@kasralainy.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Heba Wagih, MD
Email
heba.wageih@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Nagy, MD
Email
mnmo75@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32335895
Citation
Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Results Reference
derived
Learn more about this trial
Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections
We'll reach out to this number within 24 hrs