Parvovirus B19 InfectionParvoPreNCT07338279
Parvovirus B19 Infection in Pregnancy: Clinical Manifestations and Fetus/Newborn Outcome
An observational study of Parvovirus B19 Infection and Pregnancy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 5 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parvovirus B19 Infection, Pregnancy
- What is being tested?
- Collection of clinical data.
- How many people
- 150 participants
- Where
- 5 sitesItaly
- Study dates
- 6 Mar 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- Pregnant women >18 years with parvovirus B19 infection and their neonates.
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Not yet recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
Anna Fichera, MD, anna.fichera@unibs.it
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Beatrice Tassis, MD, beatrice.tassis@policlinico.mi.it
- Recruiting
ASST Fatebenefratelli Sacco
Milan, 20157
Valeria Savasi, MD, valeria.savasi@unimi.it
- Not yet recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Sara Ornaghi, MD, sara.ornaghi@unimib.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Lombardy, 27100
Daniele Lilleri, +39 0382 502420, d.lilleri@smatteo.pv.it
About this study
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
- Being tested
- Collection of clinical data.
- Medical subject headings
- Erythema Infectiosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of clinical data.Other
Observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of fetuses/newborns with intrauterine B19V infection.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From diagnosis of parvovirus B19 infection in pregnancy to delivery.
Percentage of fetuses receiving intrauterine transfusion.
Measured: 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.
Measured: From diagnosis of parvovirus B19 infection in pregnancy to 20/30 days of life of the newborn.
Percentage of infants with neurologic abnormalities.
Measured: From birth to 2 years of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start6 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parvovirus B19 InfectionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, ASST Fatebenefratelli Sacco, Fondazione IRCCS San Gerardo dei Tintori, Asst Degli Spedali Civili Di Brescia
- Responsible party
- Principal investigator, Daniele Lilleri, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338279
- Sponsor's protocol ID
- ParvoPre
- Acronym
- ParvoPre
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parvovirus B19 Infection in Pregnancy: Clinical Manifestations and Fetus/Newborn Outcome
- ClinicalTrials.gov ID
- NCT07338279
- Acronym / sponsor ID
- ParvoPre / ParvoPre
- Conditions
- Parvovirus B19 Infection, Pregnancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, ASST Fatebenefratelli Sacco, Fondazione IRCCS San Gerardo dei Tintori, Asst Degli Spedali Civili Di Brescia
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (1 listed)
- Pregnant women >18 years with parvovirus B19 infection and their neonates.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of clinical data.Observational study | Other | – |
Primary outcome
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.
5 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parvovirus B19 Infection and Pregnancy, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 5 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniele Lilleri (+39 0382 502420, d.lilleri@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.