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Phase 3 Completed N=30 Randomized Single-blind Basic Science

Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline

Cesarean Section; Infection · Surgical Site Infection
Source: ClinicalTrials.gov NCT03640507 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Post-intervention Aerobic Bacterial Colony Counts — 2.959; 0.945; 5.104 Log (CFU/mL)
◆ Published Evidence
Established
65citations · ~11 / year
Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections.
The Cochrane database of systematic reviews · 2020 · Open access · Likely link

Summary

The purpose of this study is to see whether chlorhexidine is superior to povidine-iodine vaginal antisepsis at reducing bacteria colony counts in pregnant women by comparing three groups: vaginal washing with chlorhexidine-alcohol, vaginal washing with povidine-iodine, and vaginal washing with saline alone.

Linked Publications (2)

  • Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections.
    The Cochrane database of systematic reviews · 2020 · 65 citations · Open access · Likely link
  • A randomized trial of the bactericidal effects of chlorhexidine vs povidone-iodine vaginal preparation.
    American journal of obstetrics & gynecology MFM · 2020 · 15 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-intervention Aerobic Bacterial Colony Counts
2.959; 0.945; 5.104
PRIMARY
Post-intervention Anaerobic Bacterial Colony Counts
4.934; 2.637; 5.804
SECONDARY
Baseline Aerobic Bacterial Colony Counts
5.942; 5.667; 6.480
SECONDARY
Baseline Anaerobic Bacterial Colony Counts
7.096; 6.745; 7.145

Eligibility Criteria

Intervention Group (vaginal preparation)

Inclusion Criteria

  • Pregnant women admitted for cesarean delivery
  • Gestational age greater than or equal to 34 weeks

Exclusion Criteria

  • Rupture of membranes or active labor
  • Chorioamnionitis (prior to enrollment)
  • Recent (within 4 weeks) antibiotic exposure
  • Maternal HIV infection or immunocompromised state
  • Known allergy to shellfish, iodine, or chlorhexidine
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03640507) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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