Biochemical tests for the diagnosis of premature rupture of membranes
According to the results of clinical studies published in English-language and Russian literatures in open-access databases, the author has determined the importance and efficiency of biochemical tests for the diagnosis of premature rupture of membranes. Placental alpha microglobulin-1 (PAMG-1) has a lower detection limit of amniotic fluid than insulin-like growth factor binding protein-1 (IGFBP-1), with increased sensitivity (at 1:40 and 1:80 dilutions; p < 0.05), shorter response time, and better reproducibility (p < 0.05). The specificity and positive predictive value of PAMG-1 are considerably higher than those of IGFBP-1. The test kit for PAMG-1 is most effective, as compared to that for IGFBP-1, and can help avoid misdiagnosis and unnecessary hospitalization.Baev O.R., Dikke G.B.
Keywords
premature rupture of membranes
fetal fibronectin (fFN)
insulin-like growth factor binding protein-1 (IGFBP-1)
placental alpha microglobulin-1 (PAMG-1)
References
1. Kurdoglu M., Kolusari A., Adali E., Yildizhan R., Kurdoglu Z., Kucukaydin Z. et al. Does residual amniotic fluid after preterm premature rupture of membranes have an effect on perinatal outcomes? 12 years’experience of a tertiary care center. Arch. Gynecol. Obstet. 2010; 281(4): 601-7.
2. Серов В.Н., Сухих Г.Т., ред. Акушерство и гинекология. Клинические рекомендации. 4-е изд. М.: ГЭОТАР-Медиа; 2014. [Serov V.N., Sukhikh G.T., ed. Obstetrics and gynecology. Clinical recommendations. 4th ed. Moscow: GEOTAR-Media; 2014. (in Russian)]
3. American College of Obstetricians and Gynecologists; Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin no. 127: Management of preterm labor. Obstet. Gynecol. 2012; 119(6): 1308-17.
4. Alabama Perinatal Excellence Collaborative (APEC). Guidelines Premature Rupture of Membranes. 2013. Protocol 9. Version 3. Available at: www.apecguidelines.org
5. Preterm Prelabour Rupture of the Membranes. Guideline no.24. Institute of Obstetricians and Gynaecologists, Royal College of Physicians of Ireland, Directorate of Strategy and Clinical Care, Health Service Executive. 2013. Version 1.0. Available at: // www.hse.ie/eng/about/Who
6. Mohr T. Premature rupture of the membranes. Gynakol. Geburtsmed. Gynakol. Endokrinol. 2009; 5(1): 28-36.
7. Romero R., Chaiworapongsa T., Savasan Z.A., Hussein Y., Dong Z., Kusanovic J.P. et al. Clinical chorioamnionitis is characterized by changes in the expression of the alarmin HMGB1 and one of its receptors, sRAGE. J. Matern. Fetal Neonatal Med. 2012; 25(6): 558-67.
8. Frenette P., Dodds L., Armson B.A., Jangaard K. Preterm prelabour rupture of membranes: effect of latency on neonatal and maternal outcomes. J. Obstet. Gynaecol. Can. 2013; 35(8): 710-7.
9. van der Ham D.P., van Melick M.J., Smits L., Nijhuis J.G., Weiner C.P., van Beek J.H. et al. Methods for the diagnosis of rupture of the fetal membranes in equivocal cases: a systematic review. Eur. J. Obstet. Gynecol. Reprod. Biol. 2011; 157(2): 123-7.
10. Алеев И.А. Преждевременный разрыв плодных оболочек. Информационное письмо. Радзинский В.Е., Ордиянц И.М., ред. М.: Медиабюро StatusPraesens; 2011. 20с. [Aleev I.A. Premature rupture of membranes. Information mail. Radzinsky V.E., Ordiyants I.M., ed. Мoscow: Media Bureau StatusPraesens; 2011. 20p. (in Russian)]
11. Caughey A.B., Robinson J.N., Norwitz E.R. Contemporary diagnosis and management of preterm premature rupture of membranes. Rev. Obstet. Gynecol. 2008 Winter; 1(1): 11-22.
12. Senanayake H.M. Actim PROM, AmniSure, and ROM +plus: Rupture of membrane kits tested on amniotic fluid from women at C-section: a comparative study. Sri Lanka J. Obstet. Gynaecol. 2014; 35(4): 116-21.
13. Abdelazim I.A. Insulin-like growth factor binding protein-1 (Actim PROM test) for detection of premature rupture of fetal membranes. J. Obstet. Gynaecol. Res. 2014; 40(4): 961-7.
14. Lee S.E., Park J.S., Norwitz E.R., Kim K.W., Park H.S., Jun J.K. Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet. Gynecol. 2007; 109(3): 634-40.
15. Khooshideh M., Radi V., Hosseini R., Hosseini L. The accuracy of placental alpha-microglobuline-1 test in diagnosis of premature rupture of the membranes. Iran. J. Reprod. Med. 2015; 13(6): 355-60.
16. Abdelazim I.A., Makhlouf H.H. Placental alpha microglobulin-1 (AmniSure) test) for detection of premature rupture of fetal membranes. Arch. Gynecol. Obstet. 2012; 285(4): 985-9.
17. Vischio A.T., Kuhlmann P., Ross L., Ovittore L., Sena S., Dodge J. AmniSure placental alpha microglobulin-1 rapid immunoassay for detection of rupture of membranes: a comparison study with clinical-based testing. Am. J. Clin. Pathol. 2012; 138(Suppl.1: Abstracts of the 2011 ASCP Annual Meeting/WASPaLM XXVI World Congress. October 20-22, 2012. Las Vegas, Nevada, USA.): A024.
18. Doret M., Cartier R., Miribel J., Massardier J., Massoud M., Bordes A. et al. Premature preterm rupture of the membrane diagnosis in early pregnancy: PAMG-1 and IGFBP-1 detection in amniotic fluid with biochemical tests. Clin. Biochem. 2013; 46(18): 1816-9.
19. Abdelazim I.A., Makhlouf H.H. Placental alpha microglobulin-1 (AmniSure test) versus insulin-like growth factor binding protein-1 (Actim PROM test) for detection of premature rupture of fetal membranes. J. Obstet. Gynaecol. Res. 2013; 39(6): 1129-36.
20. Marcellin L., Anselem O., Guibourdenche J., De la Calle A., Deput-Rampon C., Cabrol D., Tsatsaris V. Comparison of two bedside tests performed on cervicovaginal fluid to diagnose premature rupture of membranes. J. Gynecol. Obstet. Biol. Reprod. (Paris). 2011; 40(7): 651-6.
21. Pollet-Villard M., Cartier R., Gaucherand P., Doret M. Detection of placental alpha microglobulin-1 versus insulin-like growth factor-binding protein-1 in amniotic fluid at term: A comparative study. Am. J. Perinatol. 2011; 28(6): 489-94.
22. Birkenmaier A., Ries J.J., Kuhle J., Bürki N., Lapaire O., Hösli I. Placental α-microglobulin-1 to detect uncertain rupture of membranes in a European cohort of pregnancies. Arch. Gynecol. Obstet. 2012;285(1): 21-5.
23. Gallot D., Guibourdenche J., Sapin V., Goffinet F., Doret M., Langer B. et al. Which biological test to confirm rupture of membranes? J. Gynecol. Obstet. Biol. Reprod. (Paris). 2012; 41(2): 115-21.
24. Ramsauer B., Vidaeff A.C., Hösli I., Park J.S., Strauss A., Khodjaeva Z. et al. The diagnosis of rupture of fetal membranes (ROM): a meta-analysis. J. Perinat. Med. 2013; 41(3): 233-40.
25. Palacio M., Kühnert M., Berger R., Larios C.L., Marcellin L. Meta-analysis of studies on biochemical marker tests for the diagnosis of premature rupture of membranes: Comparison of performance indexes. BMC Pregnancy Childbirth. 2014; 14: 183.
26. Lee S.M., Lee J., Seong H.S., Lee S.E., Park J.S., Romero R., Yoon B.H. The clinical significance of a positive Amnisure testtm in women with term labor with intact membranes. J. Matern. Fetal Neonatal Med. 2009; 22(4): 305-10.
27. Mariona F.G., Roura L.C. The role of placental alpha microglobulin-1 Amnisure in determining the status of the fetal membranes; its association with preterm birth. J. Matern. Fetal Neonatal Med. 2016; 29(6): 1016-20.
28. Mittal P., Romero R., Soto E., Cordoba M., Chang C.L., Vaisbuch E. et al. A role for placental alpha-microglobulin-1 in the identification of women with a sonographic short cervix at risk for spontaneous rupture of membranes. Am. J. Obstet. Gynecol. 2009; 201(6, Suppl.): S196-7.
29. Neil P.R.L., Wallace E.M. Is AmniSure® useful in the management of women with prelabor rupture of the membranes? Aust. N. Z. J. Obstet. Gynecol. 2010; 50(6): 534-8.
30. Silva E., Martinez J.C. Diagnosing ROM: a comparison of the gold standard, indigo carmine amnioinfusion, to the rapid immunoassay, the AmniSure ROM test. J. Perinat. Med. 2009; 37(Suppl.1): 956.
31. Tagore S., Kwek K. Comparative analysis of insulin-like growth factor binding protein-1 (IGFBP1), placental alpha-microglobulin-1 (PAMG-1) and nitrazine test to diagnose premature rupture of membranes in pregnancy. J. Perinat. Med. 2010; 38(6): 609-12.
32. United States Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH): Actim®PROM Test (Alere™ Inc., Waltham MA). Summary of Safety and Effectiveness. No. K061886. Rockville, MD: FDA. January 25, 2007. Available at: http://www.accessdata.fda.gov/
33. Di Renzo G.C., Cabero Roura L., Facchinetti F., Helmer H., Hubinont C., Jacobsson B. et al. Preterm labor and birth management recommendations from the european association of perinatal medicine. J. Matern. Fetal Neonatal Med. 2017; 30(17): 2011-30.
34. Баев О.Р., Васильченко О.Н., Кан Н.Е., Клименченко Н.И., Митрохин С.Д., Тетруашвили Н.К., Ходжаева З.С., Шмаков Р.Г., Дегтярев Д.Н., Тютюнник В.Л. Преждевременный разрыв плодных оболочек (преждевременное излитие вод). Акушерство и гинекология. 2013; 9: 123-34. [Bayev O.R., Vasil’chenko O.N., Kan N.Ye., Klimenchenko N.I., Mitrokhin S.D., Tetruashvili N.K., Khodzhayeva Z.S., Shmakov R.G., Degtyarev D.N., Tyutyunnik V.L. Premature rupture of membranes (premature discharge of water). Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2013; (9): 123-34. (in Russian)]
35. Селина Н.В., Карахалис Л.Ю., Андреева М.Д., Томашевский Д.В. Преждевременное излитие вод при недоношенной беременности. Проблемы репродукции. 2012; 4: 91-5. [Selina N.V., Karakhalis L.Yu., Andreyeva M.D., Tomashevskiy D.V. Premature discharge of water with premature pregnancy. Problemy reproduktsii. 2012; 4: 91-5. (in Russian)]
36. Постановление Главного государственного санитарного врача Российской Федерации от 18 мая 2010 г. № 58 Об утверждении СанПиН 2.1.3.2630-10 „Санитарно-эпидемиологические требования к организациям, осуществляющим медицинскую деятельность”. Зарегистрировано Минюстом России 9 августа 2010 г. Регистрационный № 18094. Available at: http://pravo.gov.ru/ [The resolution of the Chief state sanitary doctor of the Russian Federation from may, 18th, 2010 № 58 On approval SanPiN 2.1.3.2630-10 “Sanitary-epidemiological requirements for organizations engaged in medical activities”. Registered by Ministry of justice of Russia on August 9, 2010 Registration No. 18094. Available at: http://pravo.gov.ru/ (in Russian)]
37. Тажетдинов Е.Х., Апресян С.В., Гагаев Ч.Г. Эффективность экспресс-теста, основанного на определении плацентарного α-микроглобулина в диагностике преждевременного разрыва плодных оболочек. Фарматека. 2014; 4: 44-5. [Tazhetdinov Ye.Kh., Apresyan S.V., Gagayev Ch.G. The effectiveness of the rapid test based on the determination of placental α-microglobulin in the diagnosis of premature rupture of membranes. Farmateka. 2014; 4: 44-5. (in Russian)]
38. Баев О.Р., Васильченко О.Н., Румянцева В.П., Шахмаева А.Б., Козлова О.А. Точность диагностики преждевременного разрыва плодных оболочек и самостоятельное использование теста определения ПАМГ-1 беременной. Акушерство и гинекология. 2014; 3: 39-43. [Baev O.R., Vasilchenko O.N., Rumyantseva V.P., Shakhmaeva A.B., Kozlova O.A. The accurate diagnosis of premature rupture of membranes and the use of placental alpha-microglobulin-1 test by a pregnant woman without any assistance. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2014; (3): 39-43. (in Russian)]
39. Болотских В.М., Захарова В.Ю., Кузьминых Т.У. Клинико-экономическое обоснование применения теста AmniSure ROM в акушерской практике. Журнал акушерства и женских болезней. 2012; 61(4): 33-9. [Bolotskikh V.M., Kuzminykh T.U., Zakharova V.Yu. Clinical and economic substantiation of application of the AmniSure ROM test in obstetric practice. Zhurnal akusherstva i zhenskikh bolezney. 2012; 4: 33-34. (in Russian)]
Received 08.06.2018
Accepted 22.06.2018
About the Authors
Baev, Oleg R., MD, professor, head of the maternity department, National Medical Research Center of Obstetrics, Gynecology, and Perinatology namedafter Academician V.I. Kulakov, Ministry of Health of Russia. 117997, Russia, Moscow, Ac. Oparina str. 4. Tel.: +74954381188. E-mail: o_baev@oparina4.ru
Dikke, Galina B., MD, Professor of the Department of Obstetrics and Gynecology with the course of reproductive medicine, F.I. Inozemtsev Academy of Medical Education. 190013, Russia, St. Petersburg, Moscow Ave, 22, letter M. Tel.: +78123347650. E-mail: galadikke@yandex.ru
For citations: Baev O.R., Dikke G.B. Biochemical tests for the diagnosis of premature rupture of membranes. Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2018; (9): 132-6. (in Russian)
https://dx.doi.org/10.18565/aig.2018.9.132-136
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