Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?
NCT ID: NCT01437228
Last Updated: 2011-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
668 participants
INTERVENTIONAL
2010-10-31
2011-04-30
Brief Summary
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Endometritis appears to result from ascending vaginal flora bacteria, with anaerobes playing an important role. The microbes endogenous to the vagina change throughout the course of pregnancy and parturition. Larsen and Galask noted that anaerobic species located in the vagina increase dramatically by the third postpartum day. In many cases, the surgeon's hand, reaching below the infant's head or presenting part, is in direct contact with the vagina. Vaginal bacterial flora have been cultured from the delivering surgeon's glove in 79% (95% confidence interval \[CI\] 58%, 100%) of cesareans that follow labor. In these cases, vaginal flora are delivered directly to the uterus, abdominal cavity, and the abdominal incision. Vaginal preparation has been shown to decrease the quantitative load of vaginal microorganisms as well as to remove certain species of bacteria.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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povidone iodine
30-second vaginal scrub with povidone- iodine solution.
povidone- iodine solution.
%10 Polivinilpirolidon iyot (Polividon- iyot
CONTROL
placebo
NO İNTERVENTİON
Interventions
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povidone- iodine solution.
%10 Polivinilpirolidon iyot (Polividon- iyot
placebo
NO İNTERVENTİON
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Allergy to povidone iodine
* Chorioamnionitis on admission
* Fever on admission
18 Years
40 Years
FEMALE
Yes
Sponsors
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Erzincan Military Hospital
OTHER
Responsible Party
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Kemal GUNGORDUK
Mardin Women and Children Hospital
Locations
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Sisli Etfal Hospital
Istanbul, Sisli, Turkey (Türkiye)
Countries
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References
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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.
Other Identifiers
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gungorduk13
Identifier Type: -
Identifier Source: org_study_id