Screening for and treatment of asymptomatic candidiasis to prevent preterm birth: A pilot study

In pregnant women with asymptomatic candidiasis does treatment with clotrimozole compared with no treatment reduce the incidence of preterm birth?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001052224

Acronym

CiPS

Enrollment

500

Registered

2009-12-09

Start date

2008-06-12

Completion date

2009-12-18

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

This is a pilot study to assess the fesaibility of a larger study aimed at answering the clinical question: 'In pregnant women with asymptomatic candidiasis does treatment reduce the incidence of preterm birth?'

Interventions

Clotrimazole 100mg pessaries for 6 days. This change was made prior to commencement of the pilot study. Amendment to protocol submitted and approved by HREC.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Asymptomatic candidiasis Singleton Pregnancy Before 20 weeks gestation

Exclusion criteria

Multiple Pregnancy, Symptomatic vaginal infection

Outcome results