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Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Fondazione Onlus Camillo De Lellis.
Recruitment status was:  Recruiting
Regione Abruzzo, Italy
Azienda Sanitaria Locale di Pescara
Information provided by (Responsible Party):
Dr. Giustino Parruti, Azienda Sanitaria Locale di Pescara Identifier:
First received: August 1, 2012
Last updated: August 3, 2012
Last verified: August 2012
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.

Condition Intervention
Cytomegalovirus Congenital Infection
Biological: standard intravenous immunoglobulin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection

Resource links provided by NLM:

Further study details as provided by Fondazione Onlus Camillo De Lellis:

Primary Outcome Measures:
  • Prevention of neurological damage due to Cytomegalovirus congenital infection [ Time Frame: Neonates will be followed for 5 years, that is the estimated period of time over which late neurological manifestations may ensue ]
    Number of infected newborns with neurological deficits divided by the total number of infected newborns

Secondary Outcome Measures:
  • Evaluate safety of aspecific immunoglobulins in pregnant women with primary CMV infection [ Time Frame: Participants are followed during the infusion period, an expected average of 5 hours; possible minor side-effects are searched for at each follow up visit ]
    Number of women with symptoms or adverse events during infusions divided by the total number of treated women

Estimated Enrollment: 300
Study Start Date: October 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: standard intravenous immunoglobulin
Single arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls.
Biological: standard intravenous immunoglobulin
Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection

Detailed Description:

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pregnant women with confirmed primary CMV infection at any stage of gestation.

Exclusion Criteria:

  • Pregnant women with falsely positive CMV IgM antibodies or high (>40%) CMV IgG avidity indexes
  Contacts and Locations
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Please refer to this study by its identifier: NCT01659684

Infection Disease Unit, Pescara General Hospital, Pescara, Italy Recruiting
Pescara, Abruzzo, Italy, 65124
Contact: Francesca D'Arcangelo, MD   
Contact: Antonina Sciacca, Secretary   
Sponsors and Collaborators
Fondazione Onlus Camillo De Lellis
Regione Abruzzo, Italy
Azienda Sanitaria Locale di Pescara
Principal Investigator: Giustino Parruti, MD, PhD Azienda Sanitaria Locale di Pescara
  More Information

Additional Information:
Responsible Party: Dr. Giustino Parruti, MD, PhD, Azienda Sanitaria Locale di Pescara Identifier: NCT01659684     History of Changes
Other Study ID Numbers: IVIG-001
Study First Received: August 1, 2012
Last Updated: August 3, 2012

Keywords provided by Fondazione Onlus Camillo De Lellis:
congenital CMV infection
standard immunoglobulins
immunoglobulin therapy
IgG CMV avidity index

Additional relevant MeSH terms:
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017