Parvovirus B19 Infection in Pregnancy: Clinical Manifestations and Fetus/Newborn Outcome

Fondazione IRCCS Policlinico San Matteo di Pavia150 enrolled

Overview

The goal of this observational study is to define the rate of intrauterine parvovirus B19 infection and fetal/newborn complications after parvovirus B19 infection of pregnant women. Secondary objectives are risk factors, pregnancy outcomes, long-term sequelae and efficacy of the management interventions.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Parvovirus B19 Infection Pregnancy

Interventions

Collection of clinical data.OTHER

Observational study

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women \>18 years with parvovirus B19 infection and their neonates. Exclusion Criteria: * None

Locations (5)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

RECRUITING

ASST degli Spedali Civili di Brescia

Brescia, Italy

NOT_YET_RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

Outcomes

Primary Outcomes

Percentage of fetuses/newborns with intrauterine B19V infection.

Time frame: From diagnosis of parvovirus B19 infection in pregnancy to 24/48 hours of life of the newborn.

Percentage of fetuses/newborns with complications due to B19V intrauterine infection.

Time frame: From diagnosis of parvovirus B19 infection in pregnancy to 24/48 hours of life of the newborn.

Secondary Outcomes

Percentage of women with symptomatic B19V infection.

Time frame: At diagnosis of parvovirus B19 infection in pregnancy

Percentage of fetuses with B19V disease.

The following findings will be considered: anemia, hydrops, ascites, pericardial effusion, pleural effusion, subcutaneus oedema, cardiomegaly, placental thickening, cerebral abnormalities, growth retardation.

Time frame: From diagnosis of parvovirus B19 infection in pregnancy to delivery.

Percentage of fetuses receiving intrauterine transfusion.

Time frame: From diagnosis of parvovirus B19 infection in pregnancy to delivery.

Percentage of newborns with B19V disease.

The following signs/symptoms will be considered: anemia, paleness, petechiae, purpura, icterus, hepato-splenomegaly, ascites, hydrops, pleural effusion, pericardial effusion, neurologic abnormalities.

Time frame: From diagnosis of parvovirus B19 infection in pregnancy to 20/30 days of life of the newborn.

Percentage of infants with neurologic abnormalities.

Time frame: From birth to 2 years of life.

Central Contacts

Daniele Lilleri

CONTACT

+39 0382 502420 d.lilleri@smatteo.pv.it

Data from ClinicalTrials.gov

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