Biomarker tests to help diagnose preterm labour in women with intact membranes

1.1 There is currently insufficient evidence to recommend the routine adoption of Actim Partus and PartoSure to help diagnose preterm labour in women with intact membranes when transvaginal ultrasound measurement of cervical length is not available or not acceptable.

1.2 There is currently insufficient evidence to recommend the routine adoption of the Rapid fetal fibronectin (fFN) 10Q Cassette Kit (using thresholds other than 50 nanograms/millilitre [ng/ml] to guide clinical management) to help diagnose preterm labour in women with intact membranes when transvaginal ultrasound measurement of cervical length is not available or not acceptable. Recommendations on qualitative fetal fibronectin testing with a fixed threshold of 50 ng/ml are covered by NICE's guideline on preterm labour and birth, and are not affected by this diagnostics guidance.

1.3 Further research is needed on the accuracy of the tests and their effect on clinical outcomes. Centres using the tests to help diagnose preterm labour in women with intact membranes are encouraged to take part in studies to address the research considerations (see section 5.12 to section 5.16). Data are needed on: