Fetal Fibronectin Test for Preterm Labor

Aim: To evaluate the safety, effectiveness, and cost effectiveness of fetal fibronectin testing to assess preterm labor and the circumstances under which this test should be publicly funded.

Conclusions and results:
Safety: Safety data relating to fetal fibronectin testing were not identified. The risk to patients is considered to be minimal because test samples are obtained during standard speculum examinations.

Effectiveness: Negative test results provide moderate diagnostic value to identify women in suspected preterm labor not at immediate risk of preterm delivery. The evidence was insufficient to support conclusive recommendations about the diagnostic precision of fetal fibronectin testing among asymptomatic pregnant women considered to be at high risk of preterm delivery.

The value of fetal fibronectin testing in clinical decision making in Australia remains uncertain because patient management data are limited. Treatment effectiveness was not examined among women in suspected preterm labor because it was considered unlikely that testing would identify additional patients needing treatment. Treatment effectiveness was not examined among high-risk, asymptomatic women because diagnostic accuracy and patient management data provided insufficient evidence for analysis.

Cost effectiveness: The financial impact of fetal fibronectin testing for women in suspected preterm labor was estimated to cost Medicare Australia between 1.66 million and 3.04 million Australian dollars per year. However, there was some uncertainty about potential savings generated as a result of providing testing for women suspected of preterm labor. The evidence was insufficient to warrant an economic analysis of testing among high-risk, asymptomatic women.

Recommendations: MSAC determined that the test is safe, but effectiveness has not been demonstrated. MSAC does not support public funding for the test at this time. The Minister for Health and Ageing endorsed this recommendation in 2007.

Methods: MSAC conducted a systematic review of the medical literature pertaining to fetal fibronectin testing. Citations that met predefined inclusion criteria were presented in the review of evidence.

Written by: MSAC with the assistance of Birinyi-Strachan L, Bevan M, Smala A, and Hutchinson J, M-TAG Pty Ltd, IMS Health, Australia