“Eli-P-Complex” Diagnostic Test for Preconception Care in Women with History of Adverse Pregnancy Outcome: A Randomized Multicenter Trial

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.