OBJECTIVE: The purpose of this study was to determine whether knowledge of the results of a rapid fetal fibronectin test affects treatment decisions during the evaluation and treatment of possible preterm labor. Previous observational studies have suggested that a negative test might help to avoid unnecessary intervention. STUDY DESIGN: This was a randomized study of women who were between 24 weeks and 34 weeks 6 days of gestation with symptoms of preterm labor and who were seen in three community hospitals. A rapid fetal fibronectin test was performed on all subjects. Patients were assigned randomly to a group whose results were known to physician or to a group whose results were not known. Treatment decisions were at the discretion of the physician. RESULTS:One hundred eight samples were collected between September 2000 and December 2001. There were 10 positive fetal fibronectin tests. The overall prevalence of delivery within 2 weeks for the study population was 2.8%. For women who had negative fetal fibronectin test results, the hospital stay was not significantly shorter when the result was known (6.8 hours) than when it was not known (8.1 hours, P =.35). However, when the physician knew the fetal fibronectin status of women with a negative test result who were observed for >6 hours, the hospital stay was shortened 40%, to 22.7 hours from 37.8 hours (P =.04). CONCLUSION:Fetal fibronectin testing may be able to supplement clinical judgment in the evaluation of the condition of patients with symptoms of preterm labor. The greatest benefit of fetal fibronectin testing might be for the patient whom the physician judges to be at high risk for imminent delivery. In such patients, the knowledge of a negative fetal fibronectin may shorten the hospital stay.
RCT Entities:
OBJECTIVE: The purpose of this study was to determine whether knowledge of the results of a rapid fetal fibronectin test affects treatment decisions during the evaluation and treatment of possible preterm labor. Previous observational studies have suggested that a negative test might help to avoid unnecessary intervention. STUDY DESIGN: This was a randomized study of women who were between 24 weeks and 34 weeks 6 days of gestation with symptoms of preterm labor and who were seen in three community hospitals. A rapid fetal fibronectin test was performed on all subjects. Patients were assigned randomly to a group whose results were known to physician or to a group whose results were not known. Treatment decisions were at the discretion of the physician. RESULTS: One hundred eight samples were collected between September 2000 and December 2001. There were 10 positive fetal fibronectin tests. The overall prevalence of delivery within 2 weeks for the study population was 2.8%. For women who had negative fetal fibronectin test results, the hospital stay was not significantly shorter when the result was known (6.8 hours) than when it was not known (8.1 hours, P =.35). However, when the physician knew the fetal fibronectin status of women with a negative test result who were observed for >6 hours, the hospital stay was shortened 40%, to 22.7 hours from 37.8 hours (P =.04). CONCLUSION: Fetal fibronectin testing may be able to supplement clinical judgment in the evaluation of the condition of patients with symptoms of preterm labor. The greatest benefit of fetal fibronectin testing might be for the patient whom the physician judges to be at high risk for imminent delivery. In such patients, the knowledge of a negative fetal fibronectin may shorten the hospital stay.
Authors: Jolande Y Vis; Femke F Wilms; Martijn A Oudijk; Martina M Porath; Hubertina C J Scheepers; Kitty W M Bloemenkamp; Annemiek C Bolte; Jérôme Cornette; Jan B Derks; Johannes J Duvekot; Jim van Eyck; Anneke Kwee; Brent C Opmeer; Maria G van Pampus; Fred K Lotgering; Sicco A Scherjon; Krystyna M Sollie; Marc E A Spaanderman; Christine Willekes; Joris A M van der Post; Ben Willem J Mol Journal: BMC Pregnancy Childbirth Date: 2009-09-01 Impact factor: 3.007