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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01437228
Study type Interventional
Source Erzincan Military Hospital
Contact
Status Completed
Phase Phase 4
Start date October 2010
Completion date April 2011

See also
  Status Clinical Trial Phase
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Completed NCT04385680 - Chlorhexidine Vaginal Preparation for Reduction of Post-cesarean Endometritis and Sepsis Phase 1/Phase 2
Terminated NCT03478163 - Antibiotics During Intrauterine Balloon Tamponade Placement Phase 4
Not yet recruiting NCT03840889 - Secondary Postpartum Hemorrhage
Completed NCT03248297 - Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries Phase 4
Completed NCT05118984 - Efficacy of Azithromycin in MSAF Cases to Improve Maternal and Neonatal Outcomes Phase 4