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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01437228
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : November 17, 2011
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital

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.

Condition or disease Intervention/treatment Phase
Postpartum Endometritis Drug: povidone- iodine solution. Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : October 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
povidone iodine
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 Drug: placebo

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01437228

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Sisli Etfal Hospital
İstanbul, Sisli, Turkey, 32377
Sponsors and Collaborators
Erzincan Military Hospital

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Responsible Party: Kemal GUNGORDUK, Mardin Women and Children Hospital, Erzincan Military Hospital Identifier: NCT01437228     History of Changes
Other Study ID Numbers: gungorduk13
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: November 17, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
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Plasma Substitutes
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs
Blood Substitutes