Cytomegalovirus Congenital Infection Clinical Trial
Official title:
Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
Because the potential benefit of standard intravenous immunoglobulins (IVIG) - obtained from unselected donor pools including a varying proportion of donors previously exposed to CMV - has not yet been explored in pregnant women, the investigators performed a longitudinal prospective study on the possible efficacy of IVIG for prevention or therapy of fetal CMV infection.
Human IVIG are offered monthly to consecutive enrolled pregnant women with confirmed primary
CMV infection at any stage, for the prevention and treatment of fetal CMV infection. Primary
infection is defined by positive CMV IgM antibodies with absent or low titres of CMV IgG
antibodies, and either low (<40%) CMV IgG avidity indexes with positive CMV IgM AND IgG
antibodies. In addition women with indefinite avidity index and positive CMV DNA detection
in urine and/or blood samples are also considered for treatment. Standard human intravenous
immunoglobulins were chosen for their safety and efficacy, well documented in other
settings. IVIGs were used to perform all of the infusions in the study, undiluted after
reconstitution, in accordance with instructions of the manufacturer. We chose to perform
IVIG infusions using 0.5 g/Kg of body weight, to make sure that a dose of specific CMV IgG
at least comparable with that carried by HIG were infused at each time point. Infusions last
4 to 5 hours, using a double lumen line to infuse approximately 1500 mL of either 5% glucose
or saline solution in parallel with the undiluted IVIG preparation, to reduce the risk of
infusion reactions.
CMV IgG and IgM antibodies and IgG avidity indexes are assayed before and after each IVIG
infusion, within 15 minutes. Quantitative CMV DNA is amplified from whole blood and urine
samples from pregnant women and neonates, using the Real-Time PCR, and on samples of
amniotic fluid from women who required amniocentesis. The newborns will be followed for five
years after delivery.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention