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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital
ClinicalTrials.gov Identifier:
NCT01437228
First received: September 6, 2011
Last updated: November 16, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Postpartum Endometritis
Drug: povidone- iodine solution.
Drug: placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Erzincan Military Hospital:

Primary Outcome Measures:
  • rate of postpartum endometritis [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    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:
  • morbidity [ Time Frame: two days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 668
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
NO İNTERVENTİON
Other Name: NO İNTERVENTİON

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01437228

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

No publications provided

Responsible Party: Kemal GUNGORDUK, Mardin Women and Children Hospital, Erzincan Military Hospital
ClinicalTrials.gov Identifier: NCT01437228     History of Changes
Other Study ID Numbers: gungorduk13
Study First Received: September 6, 2011
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration
Turkey: Ethics Committee

Additional relevant MeSH terms:
Endometritis
Adnexal Diseases
Genital Diseases, Female
Pelvic Inflammatory Disease
Uterine Diseases
Iodine
Povidone
Povidone-Iodine
Anti-Infective Agents
Anti-Infective Agents, Local
Blood Substitutes
Growth Substances
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Plasma Substitutes
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 22, 2014