Clinical Research Directory

Inclusion Criteria: * Rh-negative women who are not sensitized to Rh0 (D) antigen between the ages of 18 and 45; * signed informed patient consent to participate in the study; * pregnancy from a Rh-positive man; * immunocompetent patients (CD 4+ counts above 200 per μl, HIV negative, or those with the virus particle count of less than 200 per μl or 400000 per ml); * body mass index should be within normal limits (\> 18.5 kg / m2 and \<30.0 kg / m2); * patients who have not received blood transfusions and / or medicinal products containing immunoglobulins in the last 6 months, in particular antibodies to Rh0 (D) antigen; * persons who do not have acute and chronic cardiovascular, neuroendocrine, kidney, liver diseases, diseases of gastrointestinal tract, respiratory system; * the results of physical, instrumental and laboratory examination of patients should be within the norma or deviations should be regarded by the researcher as clinically insignificant; * the ability, according to the researcher, to comply with all the requirements of the study protocol. Exclusion Criteria: * sensitization to Rh0 (D) antigen; * the absence of reliable anamnestic data on the prevention of Rh incompatibility in previous pregnancy (s) with the birth of a Rh-positive child; * selective IgA deficiency in the presence of antibodies against immunoglobulin A (IgA); * history of severe allergic reactions to the administration of human blood protein preparations; * hypersensitivity reactions to human donor immunoglobulins; * severe thrombocytopenia and other hemostatic disorders; * life-threatening conditions and / or complications that require intensive care / surgery, the presence of any other bleeding at the time of screening; * Rh-negative fetus; * any other concomitant decompensated diseases or acute conditions, the presence of which, according to the researcher, can significantly affect the study results; * participation in any other clinical trial in the last 3 months and throughout the study. Additional exclusion criteria: Subgroup "Pharmacokinetics" (patients included in the additional study of some pharmacokinetic parameters): * any previous disease or intervention that, according to the researcher, may affect the pharmacokinetics of the study drug, in particular, organ and bone marrow transplantation, cancers; * presence of HIV, hepatitis B, or C viruses; * presence of severe clinical and laboratory manifestations of impaired liver and kidney function