Influence of transvaginal ultrasound examination on quantitative vaginal fibronectin measurements: a prospective evaluation study.

OBJECTIVE: The most important parameter in prediction of preterm birth is the cervical length measured by transvaginal ultrasound. In cases with mid-range cervical length (10-30 mm), prediction of preterm birth is difficult. In these cases, testing for cervicovaginal fluid fetal fibronectin (fFN) can improve prediction. However, it is unclear whether transvaginal ultrasound itself influences the fFN result. The purpose of this study was to evaluate this issue independent of gestational age and cervical length.

METHODS: A prospective evaluation study with 96 cases of pregnant women at 20-41 weeks of gestation was conducted in a tertiary perinatal center. A comparison of cervicovaginal fFN samples before and immediately after transvaginal ultrasound was performed. Fetal fibronectin was measured using the Hologic Rapid fFN 10Q system. It was analyzed quantitatively and qualitatively with ≥50 ng/mL as threshold for "positive". Changes in fFN values following transvaginal ultrasound were measured.

RESULTS: Ninety-six percent (69/72) of women with a fFN concentration of <26 ng/mL before ultrasound had a corresponding fFN value <26 ng/mL after ultrasound. Ninety-three percent (13/14) of women with a fFN concentration of ≥100 ng/mL before ultrasound had a corresponding fFN value ≥100 ng/mL after ultrasound. In 80% (4/5) of women with a positive fFN sample but with a value <100 ng/mL, it turned negative (<50 ng/mL) after ultrasound. For fFN concentrations ≥100 ng/mL, there are high random fluctuations in the measurement results.

CONCLUSIONS: Fetal fibronectin values of <26 ng/mL (for "negative") and ≥100 ng/mL (for "positive") from samples taken after ultrasound provide the same qualitative information as when sampled before ultrasound. For the correct interpretation however, quantitative analysis is necessary.