Preoperative Vaginal Cleansing With Povidone Iodine and the Risk of Post Cesarean Endometritis
1 other identifier
interventional
306
1 country
1
Brief Summary
Preoperative vaginal cleansing with povidone iodine and the risk of post cesarean endometritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2015
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
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 15, 2016
CompletedFirst Posted
Study publicly available on registry
February 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFebruary 26, 2016
February 1, 2016
1.2 years
February 15, 2016
February 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects with post cesarean endometritis
Number of Subjects with post cesarean endometritis as diagnosed by fever 38.4°C and greater in first 48 hours after cesarean section with any of the following (uterine tenderness, foul smelling lochia or positive C-reactive protein)
48 hours
Secondary Outcomes (1)
Number of Subjects with allergic reaction to povidone iodine
48 hours
Study Arms (2)
povidone iodine
ACTIVE COMPARATOR153 cases undergoing cesarean sections will have preoperative vaginal cleansing with 10% povidone iodine
no vaginal cleansing
NO INTERVENTION153 cases undergoing cesarean sections
Interventions
Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall
Eligibility Criteria
You may qualify if:
- Patients 18-40 years of age who will undergo cesarean deliveries.
- Able to communicate well with the investigator \& to comply with the requirements of the entire study.
- Verbal consent obtained from subject and husband / witness before undergoing the study entry (with the understanding that consent may be withdrawn by the patient at any time without prejudice).
You may not qualify if:
- Patients with allergy to iodine containing solutions.
- Patients with ante-partum hemorrhage.
- Patients with ruptured membranes.
- Patients with any known disease that increases the risk of infection e.g. immunocompromized, those receiving steroids ...etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams maternity hospital
Cairo, 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
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of obstetrics and gynecology
Study Record Dates
First Submitted
February 15, 2016
First Posted
February 26, 2016
Study Start
April 1, 2015
Primary Completion
June 1, 2016
Study Completion
October 1, 2016
Last Updated
February 26, 2016
Record last verified: 2016-02