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

NCT01659684 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-08-08

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Congenital Infection

Interventions

BIOLOGICAL

standard intravenous immunoglobulin

Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection

Sponsors & Collaborators

  • Regione Abruzzo, Italy

    collaborator UNKNOWN

  • Azienda Sanitaria Locale di Pescara

    collaborator OTHER

  • Fondazione Onlus Camillo De Lellis

    lead OTHER

Principal Investigators

  • Giustino Parruti, MD, PhD · Azienda Sanitaria Locale di Pescara

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01659684 on ClinicalTrials.gov