Comparing the diagnostic power of qualitative and quantitative measurements of ß-hCG in cervicovaginal washing-fluid for the diagnosis of PROM

Kariman, Nour Sadat; Jafari, Elham; Amiri Moghadam, Hamid Reza; Alavimajd, Hamid; Mortazavi, Maryam

Comparing the diagnostic power of qualitative and quantitative measurements of ß-hCG in cervicovaginal washing-fluid for the diagnosis of PROM

Vol. 8, Issue 1, / April-June 2007
(pages 30-37)

Nour Sadat Kariman: - Department of Midwifery, Faculty of Nursing and Midwifery, Shaheed Beheshti University of Medical Sciences, Tehran, Iran
Elham Jafari: - Department of Midwifery, Faulty of Nursing & Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran
Hamid Reza Amiri Moghadam: - Department of Basic Sciences, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran
Hamid Alavimajd: - Department of Biostatistics, Faculty of Paramedical, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Maryam Mortazavi: - Shahid Beheshti University of Medical Sciences, Tehran, Iran

Received: 4/1/2007 Accepted: 4/1/2007 - Publisher : Avicenna Research Institute

Other Format

Abstract

Introduction: Premature rupture of membranes (PROM) is defined as rupture of membranes before the onset of labor at any time during the gestational period, which occurs in 2-25% of pregnancies. Based on complications related to PROM, such as preterm labor and increased perinatal mortalities, the importance of correct and on-time diagnosis of PROM and high false positive and negative results of diagnostic tests, this research was conducted to compare the diagnostic power of qualitative and quantitative measurements of ß-hCG in cervicovaginal washing-fluid for the diagnosis of PROM in pregnant women attending Vali-e-Asr Hospital in Zanjan, Iran during 2006. Materials & Methods: This case-control research process design was done on cervicovaginal samples collected from 86 singleton pregnancies between 14-41 weeks of gestational age. Data were collected through a questionnaire, which included demographic data, pregnancy histories and a checklist for entering the result of speculum examination, fern and nitrazine tests, ELISA and qualitative strip tests for ß-hCG. Subjects with a chief complaint of amniotic fluid leakage, who had been matched for gestational age, were divided into two 43-member groups: 1- Confirmed PROM by speculum examination, with positives result of amniotic fluid pooling, nitrazine paper test and fern test and 2- The control group undergoing speculum examination with negative results of amniotic fluid pooling, nitrazine paper test and fern test. Cervico-vaginal fluids were collected from the posterior vaginal fornix by 5ml of sterile saline irrigation and aspiration technique. Subsequently, β-hCG was checked by quantitative ELISA and one-step qualitative pregnancy test. Results: The mean β-hCG levels were 250.60±118.6mIU/ml and 6.2±10.6mIU/ml in PROM and the control groups respectively. Calculations of receiving operating characteristic curve showed that the cut-off point for ELISA was 22.32mIU/ml and its sensitivity, specificity, positive and negative predictive values and accuracy were 95.3%, 97.7%, 97.6%, 95.5% and 96%, respectively. The one-step qualitative pregnancy test was positive in 42 PROM subjects, (97.7%), and in 5 of the control group, therefore, its sensitivity, speci-ficity, positive and negative predictive values and accuracy were 97.7%, 88.4%, 89.4%, 97.5% and 93%, respectively. It seems that a very good agreement exists between the results of the two methods based on a Kappa coefficient value of 0.86. Conclusion: It seems that qualitative and quantitative measurements of cervicovaginal washing-fluid -hCG are accurate, fast and simple for the diagnosis of PROM, especially in suspicious cases.

Keywords: BHCG, Cervicovaginal discharge, Amniotic fluid, Preterm labor, Premature rupture of membrane

To cite this article:

Kariman NS, Jafari E, Amiri Moghadam HR, Alavimajd H, Mortazavi M. Comparing the diagnostic power of qualitative and quantitative measurements of ß-hCG in cervicovaginal washing-fluid for the diagnosis of PROM. J Reprod Infertil. 2007;8(1):30-37.

References

Cunningham F, Gant F, Leveno J. Williams Obstetrics. 22nd Edition. New York. McGraw-Hill. 2005.
Akercan F, Cirpan T, Kazandi M. Terek MC, Mgoyi L, Ozkinay E. The value of the insulin-like growth factor binding protein-1 in the cervical-vaginal secretion de-tected by immunochromatographic dipstick test in the prediction of delivery in women with clinically uncon-firmed preterm premature rupture of membranes. Eur J Obstet Gynecol Reprod Biol. 2005;121(2):159-63. [PubMed]
Cooper AL, Vermillion ST, Soper DE. Qualitative human chorionicgonadotropin testing of cervicovaginal washing for the detection of preterm premature rupture of membranes. Am J Obstet Gynecol. 2004;191(2): 593-6. [PubMed]
Nili F, Shams Ansari A. Neonatal complications of pre-mature rupture of membrane. Acta Medica Iranica. 2003;41(3):175-9. [Abstract]
Kim YH, Park YW, Kwon HS, Kwon JY, Him BJ. Vaginal fluid beta-Human chorionic gonadotropin level in the diagnosis of premature rupture of memb-ranes. Acta Obstet Gynecol Scand. 2005;84(8):802-5. [PubMed]
Wiberg-Itzel E, Cnattingius S, Nordstrom L. Lactate determination in vaginal fluids: a new method in the diagnosis of prelabour rupture of membranes. BJOG. 2005;112(6):754-8. [PubMed]
Erdemoglu E, Mungan T. Significance of detecting insulin-like growth factor binding protein-1 in cervico-vaginal secretions:comparison with nitrazine test and amniotic fluid volume assessment.Acta Obstet Gynecol Scand. 2004;83(7):622-6. [PubMed]
Sucak A, Moroy P, Cakmakl P. Insulin-like growth factor binding protein-1: a rapid detection of amniotic fluid leakage after amniocentesis. Turkish J Med. 2005;35:157-61.
Cousins LM, Smok DP, Lovett SM, Poeltler DM. AmniSure placental alpha microglobulin-1 rapid immunoassay versus standard diagnostic methods for detection of rupture of membranes. Am J Perinatol. 2005;22(6);317-20. [PubMed]
Esim E, Turan C, Unal O, Dansuk R, Cengizglu B. Diagnosis of premature rupture of membranes by identification of beta-hCG in vaginal washing fluid. Eur J Obstet Gynecol Reprod Biol. 2003;107(1):37-40. [PubMed]
Gurbuz A, Karateke A, Ozturkmen M, Kabaca C. Human chorionic gonadotropin assay in cervical sec-retion for accurate diagnosis of preterm labor. Int J Gynaecol Obstet. 2004;85(2):132-8. [PubMed]
Sanchez-Ramos L, Mentel C, Bertholf R, Kaunitz AM. Human chorionic gonadotropin in cervicovaginal secretions as a predictor of preterm delivery. Int J Gynaecol Obstet. 2003;83(2):151-7. [PubMed]
Garshasbi A, Ghazanfari T, Faghih Zadeh S. Beta-human chorionic gonadotropin in cervicovaginal secre-tions and preterm delivery. Int J Gynaecol Obstet. 2004;86(3):358-64. [PubMed]
Ni CY, Jia WX, Yi WM, Feng LH, Yu LZ. Practic-ability of using vaginal fluid markers in detecting pre-mature rupture of membranes. Ann Clin Biochem. 2003;40(5):542-5. [PubMed]
Anai T, Tanaka Y, Hirota Y, Mivakawa I. Vaginal fluid hCG levels for detecting premature rupture of membranes. Obstet Gynecol. 1997;89(2):261-4. [PubMed]
Li HY, Chang TS. Vaginal fluid creatinine, human chorionic gonadotropin and alpha fetoprotein levels for detecting premature rupture of membranes. Zhonghua Yi Xue Za Zhi (Taipei). 2000;63(9):686-90. [PubMed]
Mangano B, Diani F, Faccini G, Zatti N, Zardini E. Proposal of a new test for the diagnosis of PROM based on the determination of hCG in the washing fluid of the posterior vaginal fornix. Minerva Ginecol. 2000; 52(5):185-8. [PubMed]
Dawson B, Trapp R.G. Basic & Clinical Biostatistics. 4th Edition, Published by Lange Medical book/MC Grawhill company, NewYork. 2004;pp:118.