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?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000607077

Acronym

CiPS (Candida in Pregnancy Study)

Enrollment

3240

Registered

2010-07-27

Start date

2010-12-15

Completion date

2017-08-31

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 night, for 6 nights.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Pregnant women presenting for antenatal care between 12+0 and 19+6 weeks gestation with singleton pregnancies and asymptomatic candidiasis

Exclusion criteria

Pregnant women: with symptomatic candidiasis, who present beyond 20 weeks gestation or have a history of hypersensitivity to clotrimazole

Outcome results