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Phase 3 N=30 Randomized Single-blind Basic Science

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

Cesarean Section; Infection · Surgical Site Infection

Bottom Line

View on ClinicalTrials.gov: NCT03640507 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Post-intervention Aerobic Bacterial Colony Counts — 2.959; 0.945; 5.104 Log (CFU/mL)

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Chlorhexidine-alcohol (Drug); Povidine-iodine (Drug); Sterile saline (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Columbia University
Primary completion
May 2019

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 —

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.

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). 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.

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