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Does Preoperative Vaginal Preparation With Povidone-iodine Before Cesarean Delivery Reduce the Risk of Endometritis?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01437228
Enrollment
668
Registered
2011-09-20
Start date
2010-10-31
Completion date
2011-04-30
Last updated
2011-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Endometritis

Brief 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.

Interventions

DRUGpovidone- iodine solution.

%10 Polivinilpirolidon iyot (Polividon- iyot

DRUGplacebo

NO İNTERVENTİON

Sponsors

Erzincan Military Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Women older than 38 weeks estimated gestational age and required cesarean section.

Exclusion criteria

* Highly emergent cesarean * Allergy to povidone iodine * Chorioamnionitis on admission * Fever on admission

Design outcomes

Primary

MeasureTime frameDescription
rate of postpartum endometritis6 weeksEndometritis was defined here as body temperature greater than 38.5C with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination

Secondary

MeasureTime frameDescription
morbiditytwo daysInfectious 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026