Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?
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|ClinicalTrials.gov Identifier: NCT01437228|
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : November 17, 2011
Cesarean delivery rates are increasing in Turkey and a major component of this increase is cesarean on demand. Although data on the rate of cesarean delivery in Turkey is limited, a national study reported a rate of 23.8%. Infectious morbidity, consisting primarily of endomyometritis and wound infection, remains a leading cause of postoperative complications. Estimates of postcesarean infection rates range from 7% to 20%, depending on demographic and obstetric variables. Infection following cesarean delivery results in not only increased hospital stay but also increases the cost of care. Strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery, cervical dilatation during cesarean delivery, and altering the uterine position during repair of the uterine incision. Despite these interventions, endometritis is still major problem after cesarean delivery.
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.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Endometritis||Drug: povidone- iodine solution. Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||668 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||April 2011|
30-second vaginal scrub with povidone- iodine solution.
Drug: povidone- iodine solution.
%10 Polivinilpirolidon iyot (Polividon- iyot
Other Name: BATTICON Solüsyon. Adeka
|Placebo Comparator: CONTROL||
Other Name: NO İNTERVENTİON
- rate of postpartum endometritis [ Time Frame: 6 weeks ]Endometritis was defined here as body temperature greater than 38.5C with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination
- morbidity [ Time Frame: two days ]Infectious morbidity was documented using established clinical criteria. Febrile morbidity was defined as a persistent fever of at least 38C for at least 24 hours after surgery and not associated with lower abdominal or pelvic tenderness and no signs of infection elsewhere.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437228
|Sisli Etfal Hospital|
|İstanbul, Sisli, Turkey, 32377|