Svetlana G. Tsakhilova¹, Tatiana E. Sharkovskaya², Olga A. Yakimovich³, Aida M. Begizova¹, Angelina A. Malsagova¹

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¹ Moscow State University of Medicine and Dentistry, Maternity Hospital № 8, Moscow, Russia.
² Family Planning Center, Rostov-on-Don, Russia.
³ Medical Institute “REAVIZ”, Moscow, Russia.
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Abstract: Background: ELI-P-Complex is the most advanced diagnostic test designed to assess whether the female body is ready (or unready) for the normal pregnancy course and for giving birth to a healthy child. ELI-P-Complex enables the perceived abnormalities to be individually treated even prior to the pregnancy planning, thus minimizing the risk of gestational and delivery-related complications. This prospective study shows the effectiveness of ELI-P-Complex testing during preconception care in women with a history of adverse pregnancy outcomes (APO). Methods: The data were reviewed from 4519 women with a history of APO and who planned to get pregnant. Following randomization, subjects of Group A were tested with ELI-P-Complex and treated before the pregnancy based on the results obtained. Group B subjects were not examined using the ELI- P-Complex test and were prepared for pregnancy in accordance with the standard strategy of pre- conception care [1]. Results: In Group A, gestational complications (GC) were revealed in 20% of women compared to 88.7% of Group B subjects; the relative risk (RR) of GC was 11.67 (95% CI: 9.9851 to 13.6392; P < 0.0001). APO was reported in 12% of Group A subjects vs. 38.1% of Group B ones; RR of APO was 5.8908 (95% CI: 4.9365 to 7.0296; P < 0.0001). Absolutely healthy children were born from 88.1% of Group A subjects compared to 50.3% of Group B ones; RR was 7.9601 (95% CI: 6.6110 to 9.5845; P < 0.0001). The positive predictive value, sensitivity, and specificity of the test for GC were 93.82% (95% CI: 92.72% to 94.80%), 93.17% (95% CI: 92.03% to 94.20%), and 92.62% (95% CI: 91.31% to 93.78%), respectively. Conclusions: The use of ELI-P-Complex for examination and further preconception care in women with a history of APO considerably reduces GC, improves pregnancy outcomes, and increases chances of giving birth to a healthy child.

Keywords: APO-Adverse Pregnancy Outcomes, GC-Gestational Complications, RR-Relative Risk

Cite this paper: Tsakhilova, S. , Sharkovskaya, T. , Yakimovich, O. , Begizova, A. and Malsagova, A. (2015) “Eli-P-Complex” Diagnostic Test for Preconception Care in Women with History of Adverse Pregnancy Outcome: A Randomized Multicenter Trial. Advances in Reproductive Sciences, 3, 81-91. doi: 10.4236/arsci.2015.34010.

References

[1]   NICE (2012) Clinical Knowledge Summaries, Pre-Conception-Advice and Management.
http://cks.nice.org.uk/pre-conception-advice-and-management#!scenariobasis:11

[2]   The March of Dimes Data.
http://www.amputee-coalition.org/inmotion/jan_feb_06/congenital_limb_part1.html

[3]   Stirrat, G.M. (1990) Recurrent Miscarriage. The Lancet, 336, 673-675.
http://dx.doi.org/10.1016/0140-6736(90)92159-F

[4]   Regan, L., Braude, P. and Trembath, P. (1989) Influence of Past Reproductive Performance on Risk of Spontaneous Abortion. BMJ, 299, 541-545. http://dx.doi.org/10.1136/bmj.299.6698.541

[5]   Greenwood, R., Samms-Vaughan, M., Golding, J. and Ashley, D. (1994) Past Obstetric History and Risk of Perinatal Death in Jamaica. Paediatric and Perinatal Epidemiology, 8, 40-53.
http://dx.doi.org/10.1111/j.1365-3016.1994.tb00490.x

[6]   Samueloff, A., Xenakis, E.M., Berkus, M.D., Huff, R.W. and Langer, O. (1993) Recurrent Stillbirth: Significance and Characteristics. The Journal of Reproductive Medicine, 38, 883-886.

[7]   Reddy, U.M. (2007) Prediction and Prevention of Recurrent Stillbirth. Obstetrics & Gynecology, 110, 1151-1164. http://dx.doi.org/10.1097/01.AOG.0000287616.71602.d0

[8]   Radhupathy, R. (1997) Th1-Type Immunity Is Incompatible with Successful Pregnancy. Immunology Today, 18, 478- 451. http://dx.doi.org/10.1016/S0167-5699(97)01127-4

[9]   Poletaev, A.B. (2008) Immunophysiology and Immunopathology. MIA Press, Moscow.

[10]   Sukhih, G.T. and Van’ko, L.V. (2003) Immunology of Pregnancy. Russian Academy of Medical Sciences Publisher, Moscow.

[11]   Kliuchnikov, C.O., Poletaev, A.B., Budikina, T.S. and Generalova, G.A. (2001) New Immune Biotechnologies in Neonatology and Paediatrics. In: Demin, S.F. and Kliuchnikov, C.O., Eds., Lectures in Paediatrics: Pathologies in Newborns and Infants, Volume 1, RGMU, Moscow, 243-267.

[12]   Budykina, T.C. and Poletaev, A.B. (2002) Methodology for Evaluation of Fetal Pathological Development. RF Patent No. 2208791.

[13]   Kalsi, J. and Isenberg, D.A. (2000) Measurement of Natural Autoantibodies. In: Shoenfeld, Y. and Isenberg, D.A., Eds., Natural Autoantibodies, CRS Press, Boca Raton, 35-57.

[14]   Poletaev, A.B. and Morozov, S.G. (2002) Part I. Natural Autoantibodies. In: Poletaev, A.B., Morozov, S.G. and Kovaliov, I.E., Eds., The Regulatory Metasystem: Immuno-Neuro-Endocrine Regulation of General Homeostasis, Meditsina, Moscow, 5-162.

[15]   Marai, I., Carp, H., Shai, S., Shabo, R., Fishman, G. and Shoenfeld, Y. (2004) Autoantibody Panel Screening in Recurrent Miscarriages. American Journal of Reproductive Immunology, 51, 235-240.
http://dx.doi.org/10.1111/j.1600-0897.2004.00153.x

[16]   Shoenfeld, Y., Carp, H.J., Molina, V., Blank, M., Cervera, R., Balasch, J., Tincani, A., Faden, D., Lojacono, A., Doria, A., Konova, E. and Meroni, P.L. (2006) Autoantibodies and Prediction of Reproductive Failure. American Journal of Reproductive Immunology, 56, 337-344.
http://dx.doi.org/10.1111/j.1600-0897.2006.00434.x

[17]   Cohen, J., Bakimer, R. and Shoenfeld, Y. (1995) Fecundity in Autoimmune Diseases. Early Pregnancy, 1, 93-105.

[18]   Poletaev, A.B. (2010) Physiological Immunology. Micklosh Publishers, Moscow.

[19]   Poletaev, A. (2013) The Main Principles of Adaptive Immune System Function: Self-Recognition, Self-Interaction, and Self-Maintenance. In: Poletaev, A.B., Ed., Physiologic Autoimmunity and Preventive Medicine, Bentham Science Publishers, Sharjah, Oak Park and Bussum, 3-20.
http://dx.doi.org/10.2174/9781608057245113010004

[20]   Niukhnin, M.A. (2007) Autoantibodies Analysis and the Problem of Optimization of the Tactics of the Pregnant Women Treatment. PhD Dissertation, Kazan State Medical Academy, Kazan.

[21]   Poletaev, A. (2012) Maternal Immunity, Pregnancy and Child’s Health. In: Sifakis, S. and Vrachnis, N., Eds., From Preconception to Postpartum, InTech, Rijeka, 41-56.

[22]   Grabar, P. (1968) About Autoantibodies. In: Ado, A.D., Ed., Problems of Reactivity in Pathology, Meditsina, Moscow, 35-52.

[23]   Poletaev, A.B., Maltseva, L.I., Zamaleeva, R.S., Nukhnin, M.A. and Osipenko, L.G. (2007) Application of ELI-P- Complex Method in Clinical Obstetrics. American Journal of Reproductive Immunology, 57, 294-301. http://dx.doi.org/10.1111/j.1600-0897.2007.00479.x

[24]   Tauber, A.I. (2014) Reconceiving Autoimmunity: An Overview. Journal of Theoretical Biology, 375, 52-60.

[25]   Poletaev, A., Poletaeva, A., Pukhalenko, A., Zamaleeva, R., Cherepanova, N. and Frizin, D. (2014) Adaptive Maternal Immune Deviations as a Ground for Autism Spectrum Disorders Development in the Child. Folia Medica, 56, 73-80. http://dx.doi.org/10.2478/folmed-2014-0011

[26]   Serova, O.F. (2000) Pre-Gestational Treatment of the Women with Habitual Miscarriages. MD Dissertation, People’s Friendship University of Russia (RUDN), Moscow.

[27]   Makarov, O.V., Osipova, N.A. and Poletaev, A.B. (2009) Autoantibodies and Diagnosis of Pre-Eclampsy. Medicine— XXI Century, 14, 28-32.

[28]   Zamaleeva, R.S., Mal’tseva, L.I., Cherepanova, N.A., Bukatina, S.V. and Nyukhnin, M.A. (2009) Clinical Value of Definition of a Level of Regulatory Autoantibodies for an Estimation of Risk of Development of Gestosis. Prakticheskaya Meditsina, 34, 68-71.

[29]   Osipenko, L. (2005) System Dynamics in Early Health Technology Assessment: Prenatal Screening Technology. PhD Dissertation, Stevens Institute of Technology, Hoboken.