Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth
2011

Treating Vaginal Candidiasis to Prevent Preterm Birth

Sample size: 3208 publication Evidence: moderate

Author Information

Author(s): Christine L Roberts, Jonathan M Morris, Kristen R Rickard, Warwick B Giles, Judy M Simpson, George Kotsiou, Jennifer R Bowen

Primary Institution: University of Sydney

Hypothesis

Treatment of asymptomatic vaginal candidiasis with clotrimazole is associated with a 40% reduction in spontaneous preterm birth <37 weeks gestation.

Conclusion

The study aims to determine if treating asymptomatic candidiasis in pregnant women can significantly reduce the rate of spontaneous preterm birth.

Supporting Evidence

  • Previous studies suggest that treating vaginal infections may reduce preterm birth rates.
  • Observational studies have shown conflicting results regarding Candida and preterm birth.
  • A pilot study indicated a trend towards reduced preterm birth in women treated with clotrimazole.

Takeaway

This study is trying to find out if giving a medicine to pregnant women with a yeast infection can help them have their babies on time.

Methodology

A prospective, randomised, open-label, blinded-endpoint (PROBE) study design will be used to evaluate the effectiveness of clotrimazole treatment.

Potential Biases

Knowledge of Candida colonisation may influence participants' behavior regarding treatment.

Limitations

The study may not represent current clinical practice due to the absence of a placebo arm.

Participant Demographics

Pregnant women presenting for antenatal care <20 weeks gestation with singleton pregnancies.

Statistical Information

P-Value

0.009

Confidence Interval

95% CI 0.14-0.84

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-2393-11-19

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