1351 - Point of care tests to exclude pre-term labour:Quantitative Fetal Fibronectin (fFN) testing for predicting pre-term labour

Page last updated: 11 July 2016

Application Detail

Status

Closed

Description of Medical Service

Fetal fibronectin (fFN) is a glycoprotein promoting adhesion between the fetal chorion and maternal decidua. fFN is typically absent from cervicovaginal secretions between 24 and 36 weeks gestation, becoming detectable again as full term approaches. Elevated levels of fFN above 50 ng/mL in cervicovaginal secretions between 24 and 36 weeks gestation are associated with an increased risk of pre-term birth (Abbott et al, 2012).

The fFN test is a two-step procedure. The first step requires obtaining a cervicovaginal sample from a patient during standard speculum examination. The second involves processing the sample to detect and quantify the level of fFN present in the sample. fFN quantification allows precise assessment of the patients risk of pre-term labour.

Description of Medical Condition

Most women who present with signs and symptoms of preterm delivery go on to deliver at term; however, a minority will experience preterm labour. Preterm birth is regarded as delivery of an infant before 37 weeks gestation. In 2010, preterm birth made up 8.3% of all deliveries in Australia, with 45% of these births occurring at or before Week 34 (AIHW, 2012). Infants born at 34 weeks or earlier often have life-threatening medical conditions. To prevent and delay preterm birth, many women in suspected preterm labour are hospitalised and treated, while others are advised bed rest at home for significant proportions of their pregnancy.

Reason for Application

New MBS item

Medical Service Type

Investigative

Previous Application Number

Not Applicable

Associated Documentation

Application Form

-

PICO Confirmation

10 June 2013 to 19 July 2013
Consultation Protocol (PDF 515 KB)
Consultation Protocol (Word 240 KB)

Final Protocol (PDF 1176 KB)
Final Protocol (Word 234 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 414 KB)
Public Summary Document (Word 466 KB)

Meetings for this Application

PASC

15 to 16 August 2013
12 to 13 December 2013

ESC

8 to 10 October 2014

MSAC

26 to 28 November 2014