Following pregnant women with viral infections and their children
Follows pregnant women with HIV, hepatitis or arbovirus infection, and their children.
Key facts
- Who runs it
- ANRS, Emerging Infectious Diseases
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- "Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort"
- Status
- Not yet recruiting
- People taking part
- 5,160 people, planned
- Started
- Feb 2026
- Expected to end
- Dec 2039
- Type of study
- Observational, 4 groups
- Treatments tested
- Blood sampling
- Umbilical cord blood sampling
- Survey using a questionnaire
- Breast milk sampling
- Amniotic fluid sampling
- Urine sampling
- Vaginal swab
- Placenta sampling
- Record updated
- 17 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant women aged 18 or older with HIV, hepatitis B, hepatitis C or an arbovirus infection. Mothers and their children are followed after birth.
- Age
- Pregnant women: 18 years or older.
- Sex
- Female (pregnant women).
- Disease stage
- Viral infection known before pregnancy or found during pregnancy: HIV-1 or HIV-2, HBV, HCV, or symptomatic, lab-confirmed arbovirus infection. Women can join at any stage of pregnancy.
Main reasons for not taking part
- Planned delivery in a centre not in the study
- Planned absence that could get in the way of taking part
- Minors, people under guardianship or deprived of liberty by a court or authority
- Not enough oral French to understand the study
- Refusal of parental authority for the child to take part
This trial only enrols pregnant participants. The registry sentence this rests on: Cis-gender pregnant woman wishing to carry her pregnancy to term and give birth in one of the maternity units participating in the research, whatever the term of pregnancy (inclusion as soon as possible after conception, whatever the outcome);
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- Pregnant women :
- Cis-gender pregnant woman wishing to carry her pregnancy to term and give birth in one of the maternity units participating in the research, whatever the term of pregnancy (inclusion as soon as possible after conception, whatever the outcome)
- Age ≥18 years
- Viral infection studied known before pregnancy or diagnosed during pregnancy
- Signed, free, informed and written consent
- Be cared for in one of the maternity units taking part in the study; Newborns/children:
- Free, informed, written and signed consent of parental guardians
Who cannot take part
- Pregnant women :
- Planned delivery in a non-study center
- Planned absence that could hinder participation in the research
- Vulnerable population (minors, persons under guardianship or trusteeship, or persons deprived of their liberty by judicial or administrative decision)
- Level of French oral comprehension insufficient according to the investigator for the research process understanding; Newborns/children:
- Refusal of parental authority to allow newborn/child to participate in study
- Follow-up of the child planned in a center not participating in the study
- Scheduled absence of parents that could hinder the child's participation in the study
Where in France
- Centre de Méthodologie et de Gestion de BichatParis, FranceContact: Project ManagerNo longer taking part
About the trial
What the trial wants to find out
The VIROPREG study is a French prospective multicenter cohort study that aims to assess the impact of viral infections and antiviral treatments received during pregnancy on maternal and child health. The study focuses on both chronic viral infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV)] and on arbovirus infections.
Read full original descriptionShow less
This study aims at investigating the following research questions:
* What is the rate of mother-to-child transmission for each virus? * What are the effects of maternal infection on (i) pregnancy outcomes, (ii) the mother's physical and psychological health, and (iii) the fetus' health and development, with a focus on long-term psychomotor development in children born to women living with HIV? * What is the impact of antiretroviral and/or antiviral prophylactic and/or therapeutic treatments administered during pregnancy on maternal and fetal health? Mother-child pairs will be followed from pregnancy through delivery and from birth until the child reaches 7 years of age. Each mother-child pair will be enrolled into one of four cohort groups based on the maternal infection.
HIV Cohort:
Pregnant women living with HIV who participate in the research will:
* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6-8 weeks post-partum) * Participate in additional follow-up by phone call or videoconference at 4- and 7-years post-partum for research purposes * Complete questionnaires at inclusion, delivery, 4- and 7- years postpartum * In case of breastfeeding, receive follow-up care aligned with routine schedules for up to 2 years postpartum, including 2 additional visits specifically for research at 2- and 3- months postpartum. * In selected cases: provide blood, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes (pharmacological and virological analyses).
Children born to mothers living with HIV and who participate in the research will:
* Be followed according to the routine care schedule from birth until 2 years of age * Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.
HBV Cohort:
Pregnant HBV-infected women who participate in the research will:
* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6- 8 weeks post-partum) * Complete questionnaires at inclusion and delivery * Provide blood samples during follow-up visits for research purposes.
Children born to HBV-infected mothers and who participate in the research will:
* Be followed according to the routine care schedule from birth to 2 years of age * Participate in additional follow-up for research purposes at 3 months and 18-24 months of age.
HCV Cohort:
Pregnant HCV-infected women who participate in the research will:
* Be followed according to the routine care schedule from enrollment to post-natal visit usually scheduled in maternity after delivery (6 - 8 weeks post-partum) * Complete questionnaires at inclusion and delivery * Provide blood samples during follow-up visits for research purposes.
Children born to HCV-infected mothers and who participate in the research will:
* Be followed according to the routine care schedule from birth until 2 years of age * Attend additional follow-up visits scheduled at 3 and 9 months of age for research purposes.
Arbovirus Cohort:
Pregnant women infected with arbovirus who participate in the research will:
* Be followed according to the routine care schedule from enrollment to delivery * Participate in additional follow-up for research purposes at 4 years after delivery. * In case of breastfeeding, women will be monitored for research purposes at Day 7 and Day 30 postpartum * Complete questionnaires at inclusion, Day 7-10 from the inclusion, delivery and 4 years after delivery * Provide blood, amniotic fluid, placenta, umbilical cord blood, colostrum and breast milk samples during follow-up visits for research purposes.
Children born to mothers infected with arbovirus and who participate in the research will:
* Be followed according to the routine care schedule from birth until 2 years of age. * Participate in additional follow-up for research purposes at inclusion, Day 7 and Day 30 after inclusion * Participate in additional follow-up by phone call or videoconference, addressed to mothers, at 4- and 7- years of age for research purposes.
The 4 groups in the trial
- HIV-1/HIV-2 Cohort
If they consent, pregnant women living with HIV-1 or HIV-2 will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active and passive follow-up until the age of 7 years old.
Treatment: Blood sampling, Umbilical cord blood sampling, Survey using a questionnaire, and Breast milk sampling
- HBV Cohort
If they consent, pregnant women living with HBV will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old.
Treatment: Blood sampling and Survey using a questionnaire
- HCV Cohort
If they consent, pregnant women living with HCV will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old.
Treatment: Blood sampling and Survey using a questionnaire
- Arbovirus Cohort
If they consent, pregnant women with symptomatic, biologically confirmed arbovirus infection, will be enrolled in this cohort at any time of their pregnancy and will be monitored according to standard care. After delivery, their child/children will also be enrolled in the cohort for active follow-up until the age of 2 years old and passive follow-up until the age of 7 years old.
Treatment: Blood sampling, Umbilical cord blood sampling, Survey using a questionnaire, Breast milk sampling, Amniotic fluid sampling, Urine sampling, Vaginal swab, and Placenta sampling
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- "Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort."
- Plain-language title
- Following pregnant women with viral infections and their childrenGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 17 February 2026