CompletedPhase 4ACTRN12610000607077

Treatment of asymptomatic candidiasis in pregnant women for the prevention of preterm birth: a randomised trial

Does treatment of asymptomatic candidiasis in pregnant women, with clotrimazole versus usual care, prevent preterm birth?


Sponsor

Northern Sydney Central Coast Area Health Service

Enrollment

3,208 participants

Start Date

Dec 15, 2010

Study Type

Interventional

Conditions

Summary

Being born too early is a leading cause of perinatal death and morbidity. This trial seeks to determine whether screening for and treating asymptomatic candidiasis in pregnancy reduces the risk of this serious health problem. The trial will discover whether a simple treatment in pregnancy can reduce preterm birth. If positive, the results will be relevant to the management of every pregnancy.


Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This study tests whether treating a common yeast infection (candidiasis) in pregnant women who have no symptoms can help prevent preterm birth. It is for women with singleton pregnancies between 12 and 20 weeks who have been found to carry the yeast but have no symptoms.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Clotrimazole vaginal pessaries (100 mg) for daily use for 6 days. Women will be advised to insert one pessary as gently and deeply as possible into the vagina while lying on her back, preferably at ni

Clotrimazole vaginal pessaries (100 mg) for daily use for 6 days. Women will be advised to insert one pessary as gently and deeply as possible into the vagina while lying on her back, preferably at night, for 6 nights.


Locations(9)

Royal North Shore Hospital - St Leonards

NSW, Australia

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

Hornsby Ku-ring-gai Hospital - Hornsby

NSW, Australia

St George Hospital - Kogarah

NSW, Australia

Royal Hospital for Women - Randwick

NSW, Australia

Liverpool Hospital - Liverpool

NSW, Australia

Campbelltown Hospital - Campbelltown

NSW, Australia

Nepean Hospital - Kingswood

NSW, Australia

Westmead Hospital - Westmead

NSW, Australia

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ACTRN12610000607077