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Recruiting NCT07338279

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

— Observational Parvovirus B19 Infection Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Collection of clinical data..
Who it may be relevant to
Registry conditions: Parvovirus B19 Infection, Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

  • Other Collection of clinical data.
    Observational study

Primary outcome measures

  • 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 outcome measures (5)
  • Percentage of women with symptomatic B19V infection. [Time frame: At diagnosis of parvovirus B19 infection in pregnancy]
  • Percentage of fetuses with B19V disease. [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. [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.]

Eligibility criteria

Inclusion criteria

  • Pregnant women >18 years with parvovirus B19 infection and their neonates.

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Italy · 5 centers
  • Fondazione IRCCS Policlinico San Matteo — Pavia
  • ASST degli Spedali Civili di Brescia — Brescia
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
  • ASST Fatebenefratelli Sacco — Milan
  • Fondazione IRCCS San Gerardo dei Tintori — Monza

Identifiers

NCT: NCT07338279 · ParvoPre

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗