Comparison of the duo of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) and traditional clinical assessment for diagnosing premature rupture of fetal membranes
-
George Uchenna Eleje
,
Euzebus Chinonye Ezugwu
Abstract
Purpose:
To determine the diagnostic accuracy of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) compared with traditional clinical assessment (TCA) of nitrazine, ferning and pooling for the diagnosis of prelabor rupture of membranes (PROM).
Methods:
A double-blinded, multicenter clinical study was conducted between February 2015 and August 2015 among pregnant women presenting with symptoms or features suggestive of PROM between 24 and 42 weeks gestation. Confirmation of PROM was done after delivery based on the presence of any two of these criteria: delivery within 48 h to 7 days, evidence of chorioamnionitis, membranes explicitly ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. Sensitivity, specificity and accuracy were outcome measures assessed.
Results:
Two hundred and thirty-six women were recruited. Three women were excluded from the final analysis due to lack of follow-up data and failure to meet inclusion criteria. Two hundred and thirty-three women had complete data for analysis. The specificity and sensitivity values for TCA were 76.2% and 85.2%, which were lower than those of Amnioquick duo+, which were 97.6% and 97.9%, respectively. The accuracy of Amnioquick duo+ was statistically higher (97.9% vs. 83.7%; RR=1.17; 95%CI=1.10–1.24; P<0.001). In equivocal cases (pooling=negative), the accuracy of Amnioquick duo+ vs. TCA was 98.4% vs. 69.4% (RR=1.42; 95%CI=1.20–1.68; P<0.001) at ≥34 weeks gestation and 100.0% vs. 71.4% (RR=1.40; 95%CI=1.07–1.83; P=0.021) at <34 weeks gestation.
Conclusion:
The performance matrix of Amnioquick duo+® was superior to that of TCA for diagnosing PROM even in equivocal cases.
Disclaimer: Biosynex SA, which supported the study and supplied Amnioquick duo+ tests, did not get involved or participate in the study design, collection, analysis and manuscript development.
Conflict of interest: Author GE has received a financial support from Biosynex SA in order to present the preliminary result of this work at the XXI FIGO World Congress of Gynecology and Obstetrics, Vancouver, Canada, on October 4–9, 2015. Other authors declare that they have no conflict of interest.
References
[1] Kim SA, Park KH, Lee SM. Non-invasive prediction of histologic chorioamnionitis in women with preterm premature rupture of membranes. Yonsei Med J. 2016;57:461–8.10.3349/ymj.2016.57.2.461Suche in Google Scholar
[2] Phupong V, Taneepanichskul S. Prelabour rupture of membranes. J Paediatr Obstet Gynaecol. 2003;29:25–32.Suche in Google Scholar
[3] Mercer BM, Goldenberg RL, Meis PJ, Moawad AH, Shellhaas C, Das A, et al. The Preterm Prediction Study: prediction of preterm premature rupture of membranes through clinical findings and ancillary testing. The National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Am J Obstet Gynecol. 2000;183:738–45.10.1067/mob.2000.106766Suche in Google Scholar
[4] Phupong V, Taneepanichskul S. Outcome of preterm premature rupture of membranes. J Med Assoc Thai. 2000;83:640–5.Suche in Google Scholar
[5] Buyukbayrak EE, Turan C, Unal O, Dansuk R, Cengizoğlu B. Diagnostic power of the vaginal washing-fluid prolactin assay as an alternative method for the diagnosis of premature rupture of membranes. J Matern Fetal Neonatal Med. 2004;15: 120–5.10.1080/14767050410001659842Suche in Google Scholar
[6] Practice Bulletin No. 160 Summary. Premature rupture of membranes. Obstet Gynecol. 2016;127:192–4. doi: 10.1097/AOG.0000000000001261.Suche in Google Scholar
[7] Kariman N, Hedayati M, Alavi Majd Sh. The diagnostic power of cervico-vaginal fluid prolactin in the diagnosis of premature rupture of membranes. Iran Red Crescent Med J. 2012;14:541–8.Suche in Google Scholar
[8] Koike N, Oi H, Naruse K, Tsunemi T, Akasaka J, Sado T, et al. Evaluation of vaginal fluid squamous cell carcinoma antigen test in diagnosis of premature rupture of membranes. J Matern Fetal Neonatal Med. 2016;19:1–4.10.3109/14767058.2016.1172565Suche in Google Scholar
[9] AbuFaza ML, Abdelazim IA, Al-Sherbeeny MM, Rabei NH, Nair SR. AmnioQuick® Duo+ for diagnosis of premature fetal membranes rupture. Int J Reprod Contracept Obstet Gynecol. 2016;5:674–9.10.18203/2320-1770.ijrcog20160565Suche in Google Scholar
[10] Ruanphoo P, Phupong V. Evaluation of the performance of the insulin-like growth factor-binding protein-1/alpha-fetoprotein test in diagnosing ruptured fetal membranes in pregnant women. J Perinatol. 2015;35:558–60.10.1038/jp.2015.6Suche in Google Scholar
[11] Abdelazim IA, Al-Sherbeeny MM, Ibrahim MEM, Fahmy AA, Rabei NH, Khalifa AAA. Insulin-like growth factor binding protein-1/alpha-fetoprotein versus placental alpha microglobulin-1 for diagnosis of premature fetal membranes rupture. Acta Medica International. 2016;3:69–74.10.5530/ami.2016.1.15Suche in Google Scholar
[12] Deckmyn B, Chieux V, Ammeux F, Houze De L’Aulnoit D, Forzy G. [Comparison of immunochromatographic tests Actim(®) Prom and Amnioquick(®) Duo for the rapid detection of premature rupture of membranes].[Article in French]. Ann Biol Clin (Paris). 2015;73:407–11.10.1684/abc.2015.1055Suche in Google Scholar
[13] Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK. Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes. Obstet Gynecol. 2007;109:634–40.10.1097/01.AOG.0000252706.46734.0aSuche in Google Scholar
[14] Yild C, Tanir H, Sener T. Comparison of conventional methods (nitrazine test, ferning test) and placental alpha microglobulin- 1 (PAMG-1) in cervicovaginal discharge for the diagnosis of rupture of membranes. Int J Gynaecol Obstet. 2009;107 (Suppl 2):S530.10.1016/S0020-7292(09)61900-7Suche in Google Scholar
[15] 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;24:659–67.10.3109/14767058.2011.553694Suche in Google Scholar PubMed PubMed Central
[16] Eleje GU, Ezugwu EC, Ogunyemi D, Eleje LI, Ikechebelu JI, Igwegbe AO, et al. Accuracy and cost-analysis of placental alpha-microglobulin-1 test in the diagnosis of premature rupture of fetal membranes in resource-limited community settings. J Obstet Gynaecol Res. 2015;41:29–38.10.1111/jog.12475Suche in Google Scholar PubMed
[17] Cousins LM, Smok DP, Lovett SM, Poeltler DM. Amnisure placental a microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am J Perinatol. 2005;22:317–20.10.1055/s-2005-870896Suche in Google Scholar PubMed
[18] Eleje GU, Ezugwu EC, Eke AC, Eleje LI, Ikechebelu JI, Afiadigwe EA, et al. Diagnostic performance of placental alpha-microglobulin-1 test in women with prolonged pre-labour rupture of membranes. J Matern Fetal Neonatal Med. 2016;29:1291–6.10.3109/14767058.2015.1046375Suche in Google Scholar PubMed
[19] Chhabra S, Kumar N, Kalra P. AmniSure: a point of care diagnostic for preterm, term prelabor rupture of membranes. J Basic Clin Reprod Sci. 2015;4:29–32.10.4103/2278-960X.153522Suche in Google Scholar
[20] Burke C, Chin EG. Chorioamnionitis at term: definition, diagnosis, and implications for practice. J Perinat Neonatal Nurs. 2016;30:106–14.10.1097/JPN.0000000000000163Suche in Google Scholar PubMed
[21] Thomasino T, Levi C, Draper M, Neubert AG. Diagnosing rupture of membranes using combination monoclonal/polyclonal immunologic protein detection. J Reprod Med. 2013;58:187–94.Suche in Google Scholar
[22] Ault A. Quick Rupture of Membranes and Miscarriage Tests on Horizon. American Congress of Obstetricians and Gynecologists (ACOG) 2016 Annual Clinical Meeting. Abstract 25I. Available at: http://www.medscape.com/viewarticle/863833. Assessed on 30th May, 2016.Suche in Google Scholar
[23] Palacio M, Kühnert M, Berger R, Larios CL, 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;14:183.10.1186/1471-2393-14-183Suche in Google Scholar PubMed PubMed Central
[24] Rogers LC, Scott L, Block JE. Accurate point-of-care detection of ruptured fetal membranes: improved diagnostic performance characteristics with a monoclonal/polyclonal immunoassay. Clin Med Insights Reprod Health. 2016;10:15–8.10.4137/CMRH.S38386Suche in Google Scholar PubMed PubMed Central
[25] Erdemoglu E, Mungan T. Significance of detecting insulin-like growth factor binding protein-1 in cervicovaginal secretions: comparison with nitrazine test and amniotic fluid volume assessment. Acta Obstet Gynecol Scand. 2004;83:622–6.10.1111/j.0001-6349.2004.00343.xSuche in Google Scholar PubMed
[26] van der Ham DP, van Melick MJ, Smits L, Nijhuis JG, Weiner CP, van Beek JH, 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;157:123–7.10.1016/j.ejogrb.2011.03.006Suche in Google Scholar PubMed
[27] Martinez de Tejada B, Boulvain M, Dumps P, Bischof P, Meisser A, Irion O. Can we improve the diagnosis of rupture of membranes? The value of insulin-like growth factor binding protein-1. Br J Obstet Gynaecol. 2006;113:1096–9.10.1111/j.1471-0528.2006.01028.xSuche in Google Scholar PubMed
The authors stated that there are no conflicts of interest regarding the publication of this article.
©2017 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Editorial
- What’s new in preterm birth prediction and prevention?
- Academy’s Corner
- Antenatal corticosteroids: current controversies
- Review articles
- The safety of progestogen in the prevention of preterm birth: meta-analysis of neonatal mortality
- Cervical pessary for the prevention of preterm birth: is it of any use?
- Maternal and neonatal outcomes following expectant management of preterm prelabour rupture of membranes before viability
- Highlight articles
- Placental malperfusion as a possible mechanism of preterm birth in patients with Müllerian anomalies
- Nifedipine increases fetoplacental perfusion
- Effect of sleep disorders on threatened premature delivery
- Risk of recurrent preterm birth among women according to change in partner
- Biomarkers of spontaneous preterm birth: a systematic review of studies using multiplex analysis
- Influence of transvaginal ultrasound examination on quantitative vaginal fibronectin measurements: a prospective evaluation study
- Evaluation of quantitative fFn test in predicting the risk of preterm birth
- The value of ultrasound measurement of cervical length and parity in prediction of cesarean section risk in term premature rupture of membranes and unfavorable cervix
- Comparison of the duo of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) and traditional clinical assessment for diagnosing premature rupture of fetal membranes
- Efficacy of a prospective community-based intervention to prevent preterm birth
- Maternal complications in settings where two-thirds of extremely preterm births are delivered by cesarean section
- The risk of neonatal respiratory morbidity according to the etiology of late preterm delivery
- Thyroid dysfunction in preterm neonates exposed to iodine
- Congress Calendar
- Congress Calendar
Artikel in diesem Heft
- Frontmatter
- Editorial
- What’s new in preterm birth prediction and prevention?
- Academy’s Corner
- Antenatal corticosteroids: current controversies
- Review articles
- The safety of progestogen in the prevention of preterm birth: meta-analysis of neonatal mortality
- Cervical pessary for the prevention of preterm birth: is it of any use?
- Maternal and neonatal outcomes following expectant management of preterm prelabour rupture of membranes before viability
- Highlight articles
- Placental malperfusion as a possible mechanism of preterm birth in patients with Müllerian anomalies
- Nifedipine increases fetoplacental perfusion
- Effect of sleep disorders on threatened premature delivery
- Risk of recurrent preterm birth among women according to change in partner
- Biomarkers of spontaneous preterm birth: a systematic review of studies using multiplex analysis
- Influence of transvaginal ultrasound examination on quantitative vaginal fibronectin measurements: a prospective evaluation study
- Evaluation of quantitative fFn test in predicting the risk of preterm birth
- The value of ultrasound measurement of cervical length and parity in prediction of cesarean section risk in term premature rupture of membranes and unfavorable cervix
- Comparison of the duo of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) and traditional clinical assessment for diagnosing premature rupture of fetal membranes
- Efficacy of a prospective community-based intervention to prevent preterm birth
- Maternal complications in settings where two-thirds of extremely preterm births are delivered by cesarean section
- The risk of neonatal respiratory morbidity according to the etiology of late preterm delivery
- Thyroid dysfunction in preterm neonates exposed to iodine
- Congress Calendar
- Congress Calendar
