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NCT Number: NCT07338279

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

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.

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Key information

Conditions

Parvovirus B19 Infection DNA Virus Infections Erythema Erythema Infectiosum Infections Parvoviridae Infections Pregnancy Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardy, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Collection of clinical data.

Other

Observational study

Primary outcomes

  1. 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.

  2. 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

  1. Percentage of women with symptomatic B19V infection.

    Time frame: At diagnosis of parvovirus B19 infection in pregnancy

  2. Percentage of fetuses with B19V disease.

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

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

  3. Percentage of fetuses receiving intrauterine transfusion.

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

  4. 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.

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

  5. Percentage of infants with neurologic abnormalities.

    Time frame: From birth to 2 years of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniele Lilleri

CONTACT

[email protected]

+39 0382 502420

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • ASST Fatebenefratelli Sacco
  • Asst Degli Spedali Civili Di Brescia
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Fondazione IRCCS San Gerardo dei Tintori

Registry information

Acronym: ParvoPre

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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