Spontaneous Preterm birth (sPTB) is the leading cause of neonatal mortality and remains an important and challenging condition to manage Fetal fibronectin is the strongest predictor of sPTB but its utility is limited due to its low positive predicative value (PPV) as a qualitative (positive or negative) test.
Objectives This study evaluated a new quantitative fetal fibronectin (fFN) bedside test (10Q) for the prediction of sPTB in patients presenting with symptoms suggestive of threatened preterm labour.
Study design A blinded, prospective observational study of 125 symptomatic participants recruited through St. Thomas' Hospital antenatal day assessment unit and antenatal ward. Women underwent a qualitative fFN and a 10Q test between 22-35 weeks. Outcome measures were delivery within 14 days, and <37 weeks.
Results 32 (23.5%) had a positive test and 12 (9.6%) delivered within 14 days of testing. The overall rate of sPTB (<37) was 13.9% which increased progressively with increasing levels of fFN, with rates of 3.07%, 17.39%, 16.67%, 53.33% and 75% within the five categories (fFN 0-9, 10-49, 50-200, 200+, 500+) respectively. The 10Q added enhanced discrimination between high-risk and low-risk patients. 10Q <10ng/mL had a 100% negative predictive value and >200ng/mL produced a 46.7% PPV for delivery within 14 days of testing. Compared to the standard qualitative fFN threshold of ±50ng/mL, 10Q of >200ng/mL increased the positive likelihood ratio by a factor of two (8.02 V’s 3.99).
Conclusion 10Q enhances the prediction of SPTB in symptomatic women. Hence, high-risk women can be more accurately identified for targeted management.
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