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

NCT07338279 | Recruiting

• 1 other identifier: ParvoPre
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Parvovirus B19 Infection; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Percentage of fetuses/newborns with intrauterine B19V infection.

  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.

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

Secondary Outcomes (5)

• Percentage of women with symptomatic B19V infection.

  At diagnosis of parvovirus B19 infection in pregnancy

• Percentage of fetuses with B19V disease.

  From diagnosis of parvovirus B19 infection in pregnancy to delivery.

• Percentage of fetuses receiving intrauterine transfusion.

  From diagnosis of parvovirus B19 infection in pregnancy to delivery.

• Percentage of newborns with B19V disease.

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

• Percentage of infants with neurologic abnormalities.

  From birth to 2 years of life.

Interventions

Collection of clinical data. OTHER

Observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: collaborator
• Fondazione IRCCS San Gerardo dei Tintori: collaborator
• Asst Degli Spedali Civili Di Brescia: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: lead
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator

Study Sites (5)

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

ASST degli Spedali Civili di Brescia

Brescia, 25123, Italy

NOT YET RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

RECRUITING

ASST Fatebenefratelli Sacco

Milan, 20157, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori

Monza, 20900, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Erythema Infectiosum

Condition Hierarchy (Ancestors)

Parvoviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Erythema; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Infectious

Central Study Contacts

Daniele Lilleri

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 13, 2026
• Study Start: March 6, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

IT (5)