ADVANCING PRETERM BIRTH PREDICTION: A PROSPECTIVE MULTICENTRIC STUDY INVESTIGATING THE PREDICTIVE PERFORMANCE OF PARTOSURE, FETAL FIBRONECTIN, AND CERVICAL LENGTH
The prediction of preterm birth (PTB) is still a controversial topic, and many efforts have been made to identify the best predictive markers. The aim of this study was to prospectively assess the predictive performance of placental alpha macroglobulin-1 (PAMG-1), fetal fibronectin (fFN), and cervical length, both individually and combined, for the prediction of spontaneous preterm birth at 7 and 14 days in a cohort of pregnant patients with threatened preterm labor. Material and methods: Between October 2022 and April 2023, we performed a prospective observational study that evaluated 80 pregnant patients with singleton pregnancies, between 24 and 32 completed weeks of gestation. We qualitatively determined PAMG-1 (PartoSure test) and fFN from the vaginal fluid. Clinical data along with cervical length measurements were also retrieved. The predictive performance of the evaluated markers was determined using logistic regression and ROC analysis. Results: PartoSure obtained the best results for the prediction of PTB in the next 7 or 14 days. On the other hand, cervical length, at an established cut-off of 19 mm, had the lowest predictive performance for the evaluated outcomes. A combined algorithm that comprised PartoSure, fFN, and cervical length measurements achieved the best predictive performance for the prediction of PTB at 14 days. Conclusions: The combined algorithm is superior in terms of predictive performance for the prediction of PTB in the next 7 or 14 days. The PartoSure test could be used individually for the prediction of PTB, but clinicians need to correlate its results with other clinical findings.
2. Cao G, Liu J, Liu M. Global, Regional, and National Incidence and Mortality of Neonatal Preterm Birth, 1990-2019. JAMA Pediatr 2022; 176(8): 787-796.
3. Oskovi Kaplan ZA, Ozgu-Erdinc AS. Prediction of Preterm Birth: Maternal Characteristics, Ultrasound Markers, and Biomarkers: An Updated Overview. J Pregnancy 2018; 2018: 8367571.
4. Vicoveanu P, Vasilache IA, Nemescu D, et al. Predictors Associated with Adverse Pregnancy Out-comes in a Cohort of Women with Systematic Lupus Erythematosus from Romania-An Observational Study (Stage 2). J Clin Med. 2022; 11(7): 1964.
5. Vicoveanu P, Vasilache IA, Scripcariu IS, et al. Use of a Feed-Forward Back Propagation Network for the Prediction of Small for Gestational Age Newborns in a Cohort of Pregnant Patients with Thrombophilia. Diagnostics (Basel) 2022; 12(4): 1009.
6. Adam AM, Vasilache IA, Socolov D, et al. Risk Factors Associated with Severe Disease and Intensive Care Unit Admission of Pregnant Patients with COVID-19 Infection-A Retrospective Study. J Clin Med. 2022; 11(20): 6055.
7. Săndulescu MS, Văduva CC, Siminel MA, et al. Impact of COVID-19 on fertility and assisted repro-ductive technology (ART): a systematic review. Rom J Morphol Embryol. 2022; 63(3): 503-510.
8. Radu VD, Vasilache IA, Costache RC, et al. Pregnancy Outcomes in a Cohort of Patients Who Un-derwent Double-J Ureteric Stenting-A Single Center Experience Medicina(Kaunas) 2022; 58(5): 619.
9. Hernandez-Andrade E, Garcia M, Ahn H, et al. Strain at the internal cervical os assessed with quasi-static elastography is associated with the risk of spontaneous preterm delivery at ≤ 34 weeks of ges-tation. Journal of Perinatal Medicine 2015; 43(6): 657-665.
10. Albayrak E, Dogru HY, Ozmen Z, et al. Is evaluation of placenta with real-time sonoelastography during the second trimester of pregnancy an effective method for the assessment of spontaneous pre-term birth risk? Clin Imaging 2016; 40(5): 926-930.
11. Dziadosz M, Bennett TA, Dolin C, et al. Uterocervical angle: a novel ultrasound screening tool to predict spontaneous preterm birth. Am J Obstet Gynecol 2016; 215(3): 376.e1-7.
12. Impis Oglou M, Tsakiridis I, Mamopoulos A, Kalogiannidis I, Athanasiadis A, Dagklis T. Cervical length screening for predicting preterm birth: A comparative review of guidelines. J Clin Ultrasound. 2023;51(3):472-8.
13. Lee SM, Romero R, Park JW, et al. The clinical significance of a positive Amnisure test in women with preterm labor and intact membranes. J Matern Fetal Neonatal Med 2012; 25(9): 1690-1698.
14. Pirjani R, Moini A, Almasi-Hashiani A, et al. Placental alpha microglobulin-1 (PartoSure) test for the prediction of preterm birth: a systematic review and meta-analysis. J Matern Fetal Neonatal Med 2021; 34(20): 3445-3457.
15. Rouholamin S, Razavi M, Rezaeinejad M, Sepidarkish M. A diagnostic profile on the PartoSure test. Expert Rev Mol Diagn 2020; 20(12): 1163-1170.
16. Faron G, Balepa L, Parra J, Fils JF, Gucciardo L. The fetal fibronectin test: 25 years after its devel-opment, what is the evidence regarding its clinical utility? A systematic review and meta-analysis. J Matern Fetal Neonatal Med. 2020; 33(3): 493-523.
17. Ng VWY, Seto MTY, Lewis H, Cheung KW. A prospective, double-blinded cohort study using quan-titative fetal fibronectin testing in symptomatic women for the prediction of spontaneous preterm de-livery. BMC Pregnancy Childbirth 2023; 23(1): 225 / doi: 10.1186/ s12884-023-05543-3.
18. Murphy KE, Hannah ME, Willan AR, et al. Multiple courses of antenatal corticosteroids for preterm birth (MACS): a randomised controlled trial. Lancet 2008; 372(9656): 2143-2151.
19. Vogel JP, Chawanpaiboon S, Moller AB, Watananirun K, Bonet M, Lumbiganon P. The global epi-demiology of preterm birth. Best Pract Res Clin Obstet Gynaecol 2018; 52: 3-12.
20. Elias D, Campaña H, Poletta FA, et al. Preterm birth etiological pathways: a Bayesian networks and mediation analysis approach. Pediatr Res 2022; 91(7): 1882-1889.
21. Melchor JC, Khalil A, Wing D, Schleussner E, Surbek D. Prediction of preterm delivery in sympto-matic women using PAMG-1, fetal fibronectin and phIGFBP-1 tests: systematic review and meta-analysis. Ultrasound Obstet Gynecol 2018; 52(4): 442-451.
22. Nikolova T, Bayev O, Nikolova N, Di Renzo GC. Comparison of a novel test for placental alpha microglobulin-1 with fetal fibronectin and cervical length measurement for the prediction of imminent spontaneous preterm delivery in patients with threatened preterm labor. J Perinat Med 2015; 43(4): 395-402.
23. Ravi M, Beljorie M, El Masry K. Evaluation of the quantitative fetal fibronectin test and PAMG-1 test for the prediction of spontaneous preterm birth in patients with signs and symptoms suggestive of preterm labor. J Matern Fetal Neonatal Med 2019; 32(23): 3909-3914.
Once an article is accepted for publication, MSJ requests a transfer of copyrights for published articles.
COPYRIGHT TRANSFER FORM FOR
REVISTA MEDICO-CHIRURGICALĂ A SOCIETĂȚII DE MEDICI ȘI NATURALIȘTI DIN IAȘI /
THE MEDICAL-SURGICAL JOURNAL OF THE SOCIETY OF PHYSICIANS AND NATURALISTS FROM IASI
We, the undersigned authors of the manuscript entitled
warrant that this manuscript, which is submitted for publication in the REVISTA MEDICO-CHIRURGICALĂ, has not been published and it is not under consideration for publication in another journal.
- we give the consent for publication in the REVISTA MEDICO-CHIRURGICALĂ, in printed and electronic format and we transfer unconditioned and complete the copyright of this manuscript to the REVISTA MEDICO-CHIRURGICALĂ, in the event of its acceptance.
- the manuscript does not break the intellectual property rights of any other person.
- we have read the submitted version of the manuscript and we are fully responsible for the content.
Names and signatures of authors / copyright owners (the following sequence is the authorship of the article):
N.B. All the authors must sign this form