Evaluation of the Safety and Efficacy of Standard Intravenous Immunoglobulins in Pregnant Women With Primary Cytomegalovirus Infection
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedAugust 8, 2012
August 1, 2012
4.1 years
August 1, 2012
August 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevention of neurological damage due to Cytomegalovirus congenital infection
Number of infected newborns with neurological deficits divided by the total number of infected newborns
Neonates will be followed for 5 years, that is the estimated period of time over which late neurological manifestations may ensue
Secondary Outcomes (1)
Evaluate safety of aspecific immunoglobulins in pregnant women with primary CMV infection
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
Study Arms (1)
standard intravenous immunoglobulin
EXPERIMENTALSingle arm evaluation of neurological consequences of congenital CMV infection in comparison with historical untreated controls.
Interventions
Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection
Eligibility Criteria
You may qualify if:
- Pregnant women with confirmed primary CMV infection at any stage of gestation.
You may not qualify if:
- Pregnant women with falsely positive CMV IgM antibodies or high (\>40%) CMV IgG avidity indexes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Onlus Camillo De Lellislead
- Regione Abruzzo, Italycollaborator
- Azienda Sanitaria Locale di Pescaracollaborator
Study Sites (1)
Infection Disease Unit, Pescara General Hospital, Pescara, Italy
Pescara, Abruzzo, 65124, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giustino Parruti, MD, PhD
Azienda Sanitaria Locale di Pescara
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 8, 2012
Study Start
October 1, 2010
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
August 8, 2012
Record last verified: 2012-08