Abstract
Objective: The PartoSure™ time-to-delivery (TTD) test (AmniSure International, Boston, MA, USA) is a newly available bedside test for the prediction of time to spontaneous preterm delivery via the detection of placental alpha microglobulin-1. The objective of this study was to determine the efficacy of the test in predicting imminent delivery in 7 or 14 days from the time of testing.
Methods: The study population consisted of 101 consecutively recruited pregnant women with singleton pregnancies between 20+0 and 36+6 weeks of gestation with symptoms of preterm labor, clinically intact amniotic membranes, and minimal cervical dilatation (≤3 cm). The PartoSure™ TTD test was performed on these patients and the test-to-spontaneous-delivery interval was calculated.
Results: The PartoSure™ TTD test predicted spontaneous preterm delivery within 7 days with 90.0% sensitivity, 93.8% specificity, 97.4% negative predictive value (NPV), and 78.3% positive predictive value (PPV). The test predicted spontaneous preterm delivery within 14 days with 80% sensitivity, 96.1% specificity, 93.6% NPV, and 87.0% PPV.
Conclusion: A positive PartoSure™ TTD test in patients presenting with symptoms of preterm labor, intact membranes, and minimal cervical dilatation (≤3 cm) indicated spontaneous preterm delivery will occur within 7 days with a high degree of accuracy. A negative result indicated that spontaneous preterm delivery within 14 days is highly unlikely.
Preliminary findings of this investigation were presented at the World Congress of Perinatal Medicine in Moscow, Russia, in June 2013 by Tanja Nikolova, MD.
References
[1] American College of Obstetricians and Gynecologists, Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 127: management of preterm labor. Obstet Gynecol. 2012;119:1308–17.10.1097/AOG.0b013e31825af2f0Search in Google Scholar
[2] Antenatal corticosteroids revisited: repeat courses. NIH Consens Statement. 2000;17:1–18.Search in Google Scholar
[3] Bittar RE, da Fonseca EB, de Carvalho MH, Martinelli S, Zugaib M. Predicting preterm delivery in asymptomatic patients with prior preterm delivery by measurement of cervical length and phosphorylated insulin-like growth factor-binding protein-1. Ultrasound Obstet Gynecol. 2007;29:562–7.10.1002/uog.3989Search in Google Scholar
[4] Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, et al. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012;379:2162–72.10.1016/S0140-6736(12)60820-4Search in Google Scholar
[5] Chandiramani M, Di Renzo GC, Gottschalk E, Helmer H, Henrich W, Hoesli I, et al. Fetal fibronectin as a predictor of spontaneous preterm birth: a European perspective. J Matern Fetal Neonatal Med. 2011;24:330–6.10.3109/14767058.2010.496879Search in Google Scholar
[6] Di Renzo GC, Roura LC, Facchinetti F, Antsaklis A, Breborowicz G, Gratacos E, et al. Guidelines for the management of spontaneous preterm labor: identification of spontaneous preterm labor, diagnosis of preterm premature rupture of membranes, and preventive tools for preterm birth. J Matern Fetal Neonatal Med. 2011;24:659–67.10.3109/14767058.2011.553694Search in Google Scholar
[7] Goldenberg RL, Mercer BM, Meis PJ, Copper RL, Das A, McNellis D. The preterm prediction study: fetal fibronectin testing and spontaneous preterm birth. Obstet Gynecol. 1996;87:643–8.10.1016/0029-7844(96)00035-XSearch in Google Scholar
[8] Kiefer DG, Vintzileos AM. The utility of fetal fibronectin in the prediction and prevention of spontaneous preterm birth. Rev Obstet Gynecol. 2008;1:106–12.Search in Google Scholar
[9] Kwek K, Khi C, Ting HS, Yeo GS. Evaluation of a bedside test for phosphorylated insulin-like growth factor binding protein-1 in preterm labour. Ann Acad Med Singapore. 2004;33:780–3.Search in Google Scholar
[10] Lee SM, Lee J, Seong HS, Lee SE, Park JS, Romero R, et al. The clinical significance of a positive AmniSure test™ in women with term labor with intact membranes. J Matern Fetal Neonatal Med. 2009;22:305–10.10.1080/14767050902801694Search in Google Scholar PubMed PubMed Central
[11] Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK. Measurement of placental a-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet Gynecol. 2007;109:634–40.10.1097/01.AOG.0000252706.46734.0aSearch in Google Scholar PubMed
[12] Lee SM, Romero R, Park JW, Kim SM, Park CW, Korzeniewski SJ, et al. The clinical significance of a positive amnisure test™ in women with preterm labor and intact membranes. J Matern Fetal Neonatal Med. 2012;25:1690–8.10.3109/14767058.2012.657279Search in Google Scholar PubMed PubMed Central
[13] Paternoster D, Riboni F, Vitulo A, Plebani M, Dell’Avanzo M, Battagliarin G, et al. Phosphorylated insulin-like growth factor binding protein-1 in cervical secretions and sonographic cervical length in the prediction of spontaneous preterm delivery. Ultrasound Obstet Gynecol. 2009;34:437–40.10.1002/uog.6428Search in Google Scholar PubMed
[14] Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2006;3:CD004454.10.1002/14651858.CD004454.pub2Search in Google Scholar PubMed
[15] Ting HS, Chin PS, Yeo GS, Kwek K. Comparison of bedside test kits for prediction of preterm delivery: phosphorylated insulin-like growth factor binding protein-1 (pIGFBP-1) test and fetal fibronectin test. Ann Acad Med Singapore. 2007;36:399–402.Search in Google Scholar
[16] Ward R, Beachy JC. Neonatal complications following preterm birth. Br J Obstet Gynecol. 2003;110(Suppl 20):8–16.10.1046/j.1471-0528.2003.00012.xSearch in Google Scholar
The authors stated that there are no conflicts of interest regarding the publication of this article.
©2014 by Walter de Gruyter Berlin/Boston
Articles in the same Issue
- Frontmatter
- Review articles
- The relationship between gestational weight gain and fetal growth: time to take stock?
- Risk factors for pregnancy-associated venous thromboembolism: a review
- Academy’s Corner
- Africa is only 14 km away from my country
- Primary prevention of preterm birth
- Original articles – Obstetrics
- Mother knows best? Comparing primiparous parturients’ expectations and predictions with actual birth outcomes
- Silent chorioamnionitis and associated pregnancy outcomes: a review of clinical data gathered over a 16-year period
- Clinical factors associated with failed trials of labor in late preterm and term twin pregnancies
- Relation of placental diagnosis in stillbirth to fetal maceration and gestational age at delivery
- Evaluation of a novel placental alpha microglobulin-1 (PAMG-1) test to predict spontaneous preterm delivery
- The relationship of praise/criticism to learning during obstetrical simulation: a randomized clinical trial
- Sickle cell disease and pregnancy outcomes: population-based study on 8.8 million births
- Differences between external and internal fetal heart rate monitoring during the second stage of labor: a prospective observational study
- Perinatal management of preterm premature ruptured membranes affects neonatal prognosis
- Impact of the nitric oxide-donor pentaerythrityl-tetranitrate on perinatal outcome in risk pregnancies: a prospective, randomized, double-blinded trial
- Umbilical vein volume flow in monochorionic twin pairs at 11–14 weeks
- Gestational weight gain according to number of fetuses in Japanese women
- Original article – Fetus
- Prenatal diagnosis of sex chromosome aneuploidies and disorders of sex development – a retrospective analysis of 11-year data
- Short communication
- Reference range for amniotic fluid index measurements in a Brazilian population
- Congress Calendar
- Congress Calendar
Articles in the same Issue
- Frontmatter
- Review articles
- The relationship between gestational weight gain and fetal growth: time to take stock?
- Risk factors for pregnancy-associated venous thromboembolism: a review
- Academy’s Corner
- Africa is only 14 km away from my country
- Primary prevention of preterm birth
- Original articles – Obstetrics
- Mother knows best? Comparing primiparous parturients’ expectations and predictions with actual birth outcomes
- Silent chorioamnionitis and associated pregnancy outcomes: a review of clinical data gathered over a 16-year period
- Clinical factors associated with failed trials of labor in late preterm and term twin pregnancies
- Relation of placental diagnosis in stillbirth to fetal maceration and gestational age at delivery
- Evaluation of a novel placental alpha microglobulin-1 (PAMG-1) test to predict spontaneous preterm delivery
- The relationship of praise/criticism to learning during obstetrical simulation: a randomized clinical trial
- Sickle cell disease and pregnancy outcomes: population-based study on 8.8 million births
- Differences between external and internal fetal heart rate monitoring during the second stage of labor: a prospective observational study
- Perinatal management of preterm premature ruptured membranes affects neonatal prognosis
- Impact of the nitric oxide-donor pentaerythrityl-tetranitrate on perinatal outcome in risk pregnancies: a prospective, randomized, double-blinded trial
- Umbilical vein volume flow in monochorionic twin pairs at 11–14 weeks
- Gestational weight gain according to number of fetuses in Japanese women
- Original article – Fetus
- Prenatal diagnosis of sex chromosome aneuploidies and disorders of sex development – a retrospective analysis of 11-year data
- Short communication
- Reference range for amniotic fluid index measurements in a Brazilian population
- Congress Calendar
- Congress Calendar