Merel M C Bruijn1, Jolande Y Vis2, Femke F Wilms3, Martijn A Oudijk4, Anneke Kwee5, Martina M Porath3, Guid Oei3, Hubertina C J Scheepers6, Marc E A Spaanderman6, Kitty W M Bloemenkamp7, Monique C Haak7, Antoinette C Bolte8, Frank P H A Vandenbussche8, Mallory D Woiski8, Caroline J Bax9, Jérôme M J Cornette10, Johannes J Duvekot10, Bas W A Nij Bijvank11, Jim van Eyck11, Maureen T M Franssen12, Krystyna M Sollie12, Joris A M van der Post13, Patrick M M Bossuyt14, Brent C Opmeer15, M Kok13, Ben W J Mol16, Gert-Jan van Baaren13. 1. Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands. Electronic address: m.m.bruijn@amc.uva.nl. 2. Clinical Chemistry and Haematology, University Medical Centre Utrecht, Netherlands. 3. Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, Netherlands. 4. Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands; Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, Netherlands. 5. Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, Netherlands. 6. Obstetrics and Gynaecology, University Hospital Maastricht, Maastricht, Netherlands. 7. Obstetrics, Leiden University Medical Centre, Leiden, Netherlands. 8. Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, Netherlands. 9. Obstetrics and Gynaecology, VU University Medical Centre, Amsterdam, Netherlands. 10. Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, Netherlands. 11. Obstetrics and Gynaecology, Isala Clinics, Zwolle, Netherlands. 12. Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, Netherlands. 13. Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands. 14. Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, Netherlands. 15. Clinical Research Unit, Academic Medical Centre, Amsterdam, Netherlands. 16. The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Australia.
Abstract
OBJECTIVE: To compare the accuracy of the Actim Partus test and fetal fibronectin (fFN) test in the prediction of spontaneous preterm delivery within seven days in symptomatic women undergoing cervical length measurement. STUDY DESIGN: We performed a post-hoc analysis on frozen samples of a nationwide cohort study in all 10 perinatal centres in the Netherlands. We selected samples from women with signs of preterm labour between 24 and 34 weeks of gestational age and a cervical length below 30mm. Delivery within seven days after initial assessment was the primary endpoint. We calculated sensitivity, specificity, and positive and negative predictive values for the combination of both the Actim Partus test and fFN test with cervical length. A test was considered positive in case of a cervical length between 15 and 30mm with a positive Actim Partus or fFN test, and a cervical length below 15mm regardless the test result. RESULTS: In total, samples of 350 women were tested, of whom 69 (20%) delivered within seven days. Eighty-four women had a positive Actim Partus test and 162 women a positive fFN test, of whom 54 (64%) and 63 (39%) delivered within seven days, respectively. Ninety-seven women had a cervical length below 15mm, of whom 50 (52%) delivered within seven days. Sensitivity, specificity, positive and negative predictive values of combining cervical length with the Actim Partus test or the fFN test were 91%, 75%, 47% and 97%, and 96%, 58%, 36% and 98%, respectively. CONCLUSION: According to this post-hoc study, in combination with cervical length, the Actim Partus test could be used as an alternative for the fFN test to identify women who will not deliver within seven days after presentation. Further evidence should be collected in a prospective comparative study.
OBJECTIVE: To compare the accuracy of the Actim Partus test and fetal fibronectin (fFN) test in the prediction of spontaneous preterm delivery within seven days in symptomatic women undergoing cervical length measurement. STUDY DESIGN: We performed a post-hoc analysis on frozen samples of a nationwide cohort study in all 10 perinatal centres in the Netherlands. We selected samples from women with signs of preterm labour between 24 and 34 weeks of gestational age and a cervical length below 30mm. Delivery within seven days after initial assessment was the primary endpoint. We calculated sensitivity, specificity, and positive and negative predictive values for the combination of both the Actim Partus test and fFN test with cervical length. A test was considered positive in case of a cervical length between 15 and 30mm with a positive Actim Partus or fFN test, and a cervical length below 15mm regardless the test result. RESULTS: In total, samples of 350 women were tested, of whom 69 (20%) delivered within seven days. Eighty-four women had a positive Actim Partus test and 162 women a positive fFN test, of whom 54 (64%) and 63 (39%) delivered within seven days, respectively. Ninety-seven women had a cervical length below 15mm, of whom 50 (52%) delivered within seven days. Sensitivity, specificity, positive and negative predictive values of combining cervical length with the Actim Partus test or the fFN test were 91%, 75%, 47% and 97%, and 96%, 58%, 36% and 98%, respectively. CONCLUSION: According to this post-hoc study, in combination with cervical length, the Actim Partus test could be used as an alternative for the fFN test to identify women who will not deliver within seven days after presentation. Further evidence should be collected in a prospective comparative study.
Authors: Catherine E Majors; Chelsey A Smith; Mary E Natoli; Kathryn A Kundrod; Rebecca Richards-Kortum Journal: Lab Chip Date: 2017-10-11 Impact factor: 6.799