Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections
1 other identifier
interventional
1,200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2018
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedStudy Start
First participant enrolled
January 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 26, 2019
July 1, 2019
11 months
January 6, 2018
July 24, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Postpartum endometritis
a clinical diagnosis, usually involving fever, uterine fundal tenderness, or prurulent lochia requiring antibiotic therapy.
6 weeks after Cesarean section
Secondary Outcomes (2)
Postoperative wound infection
6 weeks after Cesarean section
Postoperative fever
3 weeks after Cesarean section
Study Arms (2)
Betadine douches
ACTIVE COMPARATORsubjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
Non betadine douches
NO INTERVENTIONsubjects didnot received a vaginal preparation prior to caesarean delivery
Interventions
subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
Eligibility Criteria
You may qualify if:
- Any patient undergoing CS
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Kasr Alainy medical school
Cairo, 12151, Egypt
Related Publications (1)
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.
PMID: 32335895DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Maged, MD
Professor
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
January 6, 2018
First Posted
January 12, 2018
Study Start
January 3, 2019
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
July 26, 2019
Record last verified: 2019-07