Does fetal fibronectin testing change patient management in women at risk of preterm labour?

www.hologic.comAug 20 2009

Hologic, Inc. has announced the publication of the first of its kind study evaluating the impact of fetal fibronectin (fFN) testing among both symptomatic and asymptomatic pregnant women at risk for preterm birth. The study, "Does fetal fibronectin testing change patient management in women at risk of preterm labour?" by researchers at King's College, London, England appears in the on-line version of the European Journal of Obstetrics & Gynecology and Reproductive Biology.

The study conducted at the Maternal and Fetal Research Unit at St. Thomas' Hospital in London included nearly 100 clinically symptomatic and asymptomatic patients between 23 and 34 weeks gestation. After using the fFN test in both populations, clinicians were asked to determine if the results from the test changed the medical management of their patients. Clinician responses indicated that fFN testing had the potential to change management in nearly 90 percent of cases. The study concluded that fFN testing has the potential to improve risk assessment and impact treatment decisions including the administering of steroids, increased surveillance, or cerclage intervention in the asymptomatic high-risk population involved in the study.

"The results of our study clearly indicate that fFN testing influenced management in a significant number of patients. A large number of women were asymptomatic at testing. Fetal fibronectin testing could be offered more widely and has the potential to benefit patient management," said Prof. Andrew Shennan, study co-author and Ob/Gyn at St Thomas' Hospital in London. "Another important benefit of fFN testing is the ability to avoid overtreatment of women with negative test results. In addition to providing assurance to women and their doctors that preterm birth is not imminent, fFN testing -- if more widely used in the asymptomatic population -- could also translate into significant cost savings to the health care system."

Hologic's fetal fibronectin test is an FDA-approved, non-invasive test that assesses the risk of preterm birth in women from 22 to 35 weeks gestation with known risk factors or with signs and symptoms of preterm labor. The fFN test measures the presence of fetal fibronectin, the glue-like substance that holds the baby in the womb. A negative result means fetal fibronectin is minimally present and there is a less than one percent chance of delivering in the next two weeks. A positive result is a strong independent predictor of preterm birth before 32 weeks.