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CompletedNCT01437228Updated Nov 17, 2011

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

A Phase 4 interventional study of povidone- iodine solution. and placebo in Postpartum Endometritis, sponsored by Erzincan Military Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-17.

Sponsored by Erzincan Military Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
668
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study 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.

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Conditions studied

  • Postpartum Endometritis
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In context

Lead sponsor

Erzincan Military Hospital is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Highly emergent cesarean
  • Allergy to povidone iodine
  • Chorioamnionitis on admission
  • Fever on admission
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Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
668 participants (actual)

Study arms

  • Other
    povidone iodine

    30-second vaginal scrub with povidone- iodine solution.

    Drug: povidone- iodine solution.

  • Placebo comparator
    CONTROL

    Drug: placebo

Interventions

  • Drugpovidone- iodine solution.

    %10 Polivinilpirolidon iyot (Polividon- iyot

    Also known as: BATTICON Solüsyon. Adeka

  • Drugplacebo

    NO İNTERVENTİON

    Also known as: NO İNTERVENTİON

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What researchers measure

Primary outcomes

  1. rate of postpartum endometritis

    Endometritis was defined here as body temperature greater than 38.5C with concomitant foul-smelling discharge or abnormally tender uterus on bimanual examination

    Time frame: 6 weeks

Secondary outcomes

  1. morbidity

    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.

    Time frame: two days

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Study locations

1 site
  • Sisli Etfal Hospital
    Istanbul, Sisli 32377, Turkey (Türkiye)
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References and documents

Publications

  • Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7. PubMed 32335895 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01437228
Lead sponsor
Erzincan Military Hospital
Responsible party
Kemal GUNGORDUK (Mardin Women and Children Hospital, Erzincan Military Hospital) — Principal investigator
First posted
Sep 20, 2011
Start date
Oct 2010
Primary completion
Mar 2011
Completion
Apr 2011
Last update
Nov 17, 2011
View the source record on ClinicalTrials.gov ↗

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