An observational study in HIV Infection, HBV Infection and HDV Infection, sponsored by ANRS, Emerging Infectious Diseases. Not yet recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by ANRS, Emerging Infectious Diseases · Observational
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.
This study aims at investigating the following research questions:
HIV Cohort:
Pregnant women living with HIV who participate in the research will:
Children born to mothers living with HIV and who participate in the research will:
HBV Cohort:
Pregnant HBV-infected women who participate in the research will:
Children born to HBV-infected mothers and who participate in the research will:
HCV Cohort:
Pregnant HCV-infected women who participate in the research will:
Children born to HCV-infected mothers and who participate in the research will:
Arbovirus Cohort:
Pregnant women infected with arbovirus who participate in the research will:
Children born to mothers infected with arbovirus and who participate in the research will:
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 5,160 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women living with either HIV and/or HBV and/or HCV and/or Arbovirus will be enrolled in the study.
After delivery, their child/children will also be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pregnant women :
Newborns/children:
- Free, informed, written and signed consent of parental guardians.
Exclusion Criteria:
Pregnant women :
Newborns/children:
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.
Biological: Blood sampling · Biological: Umbilical cord blood sampling · Other: Survey using a questionnaire · Biological: Breast milk sampling
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.
Biological: Blood sampling · Other: Survey using a questionnaire
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.
Biological: Blood sampling · Other: Survey using a questionnaire
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.
Biological: Blood sampling · Biological: Umbilical cord blood sampling · Other: Survey using a questionnaire · Biological: Breast milk sampling · Biological: Amniotic fluid sampling · Biological: Urine sampling · Biological: Vaginal swab · Biological: Placenta sampling
Blood sampling will be done to perform pharmacological and virological analysis.
Umbilical cord blood will be sampled to perform pharmacological analysis.
Questionnaires will be administered to the participant at different times during the study.
If breastfeeding, breast milk will be collected to perform pharmacological analysis.
Amniotic fluid will be sampled for virological and immunological analysis and biobanquing
Urine will be sampled for biobanquing
Vaginal swab will be sampled for biobanquing
Placenta will be sampled for virological and immunological analysis
HIV-1/HIV-2 Cohort: Scores assessing gross and fine motor skills and social-emotional development at 4 years of age
Time frame: From enrollment to the end of follow-up at the age of 4
Hepatitis B Cohort: HBV infection at 9 months of age
Time frame: From enrollment of the child to 9 months of age
Hepatitis C Cohort: HCV infection between 18 and 24 months of age
Time frame: From enrollment of the child to between 18 and 24 months of age
Arbovirus Cohort: For each arbovirus, occurrence of one of the following events defining an unfavourable pregnancy outcome, from among: o Maternal/fetal: spontaneous miscarriage, fetal death in utero, medical abortion; o Neonatal: neonatal death
Time frame: From enrollment up to 28 days of newborn's life
HIV-1/HIV-2 cohort :The impact of exposure to HIV-1/HIV-2 and antiretroviral treatment in children born to mothers living with HIV-1/HIV-2
The impact of exposure to HIV-1/HIV-2 and antiretroviral treatment will be assessed on: * Presence of major congenital malformations * HIV-1/HIV-2 infection in children * Autism spectrum disorders between 18 and 24 months old, as measured by the Modified Checklist Autism for Toddlers (M-CHAT) * Growth parameters (weight, height, head circumference) from birth to 2 years old; * Learning and coordination disorders, hyperactivity (ADHD), autistic traits assessed at 7 years old by the "Autism-Tics, ADHD and other Comorbidities" (A-TAC) questionnaire; * Hospitalizations, late-onset congenital malformations (cardiac or cerebral) and chronic illnesses occurring during the child's first 7 years of life, identified using data from:PMSI, DCIR * Death at age 7
Time frame: From enrollement of children to the age of 7 years old
HIV-1/HIV-2 cohort : Social determinants in children born to mothers living with HIV-1/HIV-2
Social determinants will be collected with the social deprivation during pregnancy index (SDI). The contribution of social determinants will be assessed on the health and development indicators at 4 and 7 years old
Time frame: From enrollment of the children to the age of 7 years old
HIV-1/HIV-2 cohort : Post-natal antiretroviral prophylaxis in children born to mothers living with HIV-1/HIV-2
Time frame: From enrollement of children to the age of 2 years old
HIV-1/HIV-2 Cohort: Obstetrical pathologies, hospitalizations and adverse pregnancy outcomes in pregnant women living with HIV-1/HIV-2
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Social determinants in pregnant women living with HIV-1/HIV-2
Social determinants will be collected using the SDI and the augmented PRECAR score.
Time frame: From enrollment of pregnant women up to the children's 7 years old
HIV-1/HIV-2 Cohort: Obstetrical management during pregnancy, including obstetrical follow-up, invasive procedures during pregnancy (trophoblast biopsy, amniocentesis) and decisions concerning the delivery method in pregnant women living with HIV-1/HIV-2
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort:Therapeutic sequences,viral load and CD4 count during pregnancy and at delivery; clinical and biological tolerance of treatments;plasma ARV assays;ARV resistance genotypes performed in routine in pregnant women living with HIV-1/HIV-2
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Quality of life in pregnant women living with HIV-1/HIV-2
Quality of life will be assessed by the WHOQOL-BREF during the delivery stay
Time frame: Delivery stay
HIV-1/HIV-2 Cohort: Adherence of women in pregnant women living with HIV-1/HIV-2
Adherence of women will be assessed through HIV-related literacy with the FCCHL (Functional, Communicative and Critical Health Literacy scale) during the delivery stay.
Time frame: Delivery stay
HIV-1/HIV-2 Cohort: Experienced discrimination and care-giver interactions in pregnant women living with HIV-1/HIV-2
Time frame: During the delivery stay and during the telephone visit at child's 4 years old
HIV-1/HIV-2 Cohort: Sharing of virological status in pregnant women living with HIV-1/HIV-2
Time frame: During the delivery stay and during the telephone visit at child's 4 years of age
HIV-1/HIV-2 Cohort: Presence of anxiety-depressive symptoms in pregnant women living with HIV-1/HIV-2
Presence of anxiety-depressive symptoms using the EPDS questionnaire
Time frame: Delivery stay
HIV-1/HIV-2 Cohort: Non-optimal access to care during pregnancy; comparison of care consumption with HAS recommendations for pregnancy monitoring
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Breast-feeding practices: in the event of breast-feeding
Time frame: During the breast-feeding period, up to 24 months after delivery
HIV-1/HIV-2 Cohort: Measurement of drug concentration in plasma in pregnant women treated with certains targeted drugs
Targeted drugs are: tenofovir alafenamide, etravirine, doravirine, rilpivirine, bictegravir,dolutegravir, cabotegravir, raltegravir, fostemsavir, lenacapavir, any new ARV not yet marketed in 2023 (islatravir, ibalizumab...)
Time frame: From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Monthly measurements of ARV drug concentration in breast milk (if breast-feeding)
Time frame: During the breast-feeding
HIV-1/HIV-2 Cohort: In breast-fed newborns, monthly measurements of plasma concentrations of the same ARVs
Time frame: During the breast-feeding
HBV Cohort: Delay between diagnosis of HBV infection and date of onset of pregnancy in HBV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Therapeutic prophylaxis practices in HBV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: HBV viral load during obstetrical follow-up and at delivery in HBV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Plasma concentrations of HBV antivirals in treated women
Time frame: At inclusion and at delivery
HBV Cohort: Maternal morbidity and mortality
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Initiation or resumption of follow-up by a hepatologist of postpartum HBV-infected women
Time frame: During the post-partum period, up to 2 months after delivery
HBV Cohort: Screening practices among close contacts of infected women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Seroprevalence of HDV in HBV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Active HDV infection (in women with positive HDV serology)
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Liver disease at fibrosis, cirrhosis and/or hepatic carcinoma stage during pregnancy in HBV-infected pregnant women (+/- HDV)
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Social determinants in HBV-infected pregnant women
Social determinants will be assessed by the social deprivation during pregnancy index (SDI) and the augmented PRECAR score
Time frame: At inclusion and during the delivery stay
HBV Cohort: Adherence of HBV-infected pregnant women
Time frame: During the delivery stay
HBV Cohort: Presence of anxiety-depressive symptoms in women living with HBV
Time frame: During the delivery stay
HBV Cohort: Experienced discrimination and care-giver interactions in HBV-infected pregnant women
Time frame: During the delivery stay
HBV Cohort: Non-optimal access to healthcare during pregnancy; study of healthcare consumption in relation to HAS recommendations for pregnancy monitoring
Time frame: From enrollment of pregnant women to delivery
HBV Cohort: Post-natal serovaccination of children and schedule
Time frame: From enrollement of children to the age of 2 years old
HBV Cohort: HBV infection in children born to HBV-infected mothers
Time frame: From birth to the age of 2 years old
HBV Cohort: Factors associated to mother-to-child transmission of HBV (maternal antiviral prophylaxis, neonatal serotherapy, vaccination, hepatitis B profile, level of viral replication, social determinants)
Time frame: During the follow-up period, up to 2 months after delivery
HBV Cohort: Timing of mother-to-child transmission in HBV-infected children
Time frame: 9 months after delivery
HBV Cohort: Hospitalizations and chronic illnesses
Time frame: From enrollement of children to the age of 7 years old
HBV Cohort: HDV infection in children born to mother co-infected with HBV/HDV
Time frame: 9 months after delivery
HCV Cohort: Socio-demographic profile of infected women
Time frame: At inclusion
HCV Cohort: Maternal morbidity and mortality events in HCV-infected pregnant women
Time frame: From enrollment of pregnant women to delivery
HCV Cohort: Management practices during pregnancy (treatment, date of initiation, dosage, duration of treatment, date of end of treatment and reason for discontinuation, if applicable); and post-partum (follow-up by an hepatologist)
Time frame: From enrollment of pregnant women up to 2 months after delivery
HCV Cohort: Liver disease at fibrosis, cirrhosis and/or hepatocellular carcinoma stage during pregnancy in HCV-infected women
Time frame: From enrollment of pregnant women to delivery
HCV Cohort: Initiation or resumption of post-partum follow-up by a hepatologist for women infected with HCV during pregnancy
Time frame: During the post-partum period, up to 2 months after delivery
HCV Cohort: HCV antiviral treatment during pregnancy
Time frame: From enrollment of pregnant women to delivery
HCV Cohort: Plasma concentrations of antivirals during pregnancy in women receiving HCV treatment
Time frame: From enrollment of pregnant women to delivery
HCV Cohort: Adherence of HCV-infected pregnant women
Time frame: During the delivery stay
HCV Cohort: Presence of anxiety-depressive symptoms in women living with HCV
Time frame: During the delivery stay
HCV Cohort: Active HCV infection in children born to HCV-infected mothers
Time frame: At 3 months of age
HCV Cohort: Diagnostic performance of PCR at 3 months between 18 and 24 months of age
Time frame: At child's 3months and 18-24 months
HCV Cohort: Spontaneous cure rate at 9 months and between 18 and 24 months of age
Time frame: At child's 9 months and 18-24 months
HCV Cohort: Morbidity criteria in the first 7 years of life
Time frame: From enrollement of children to the age of 7 years old
Arbovirosis Cohort: Occurrence of obstetrical pathologies, hospitalisations/stays in intensive care during pregnancy, other unfavourable pregnancy outcomes (premature delivery, etc.), or maternal death
Time frame: From enrollment of pregnant women to delivery
Arbovirosis Cohort: Demographic, clinical, biological, virological, immunological and genetic factors associated with, or predictive of, the occurrence of a severe course (shock, haemorrhage, visceral failure, death) of arbovirosis during pregnancy
Time frame: From enrollment of pregnant women to delivery
Arbovirosis Cohort: Quality of life in pregnant women with symptomatic, virologically confirmed arbovirus infection
Quality of life will be assessed by the EuroQol-5 Dimension (EQ5D) and by the WHOQOL-BREF
Time frame: At day 1 and between day7-10 post-infection and during the delivery stay
Arbovirosis Cohort: Effect of social determinants on the occurrence of obstetrical pathologies, hospitalisations/stays in intensive care unit during pregnancy, other adverse pregnancy outcomes (premature delivery, etc.) or maternal death
Time frame: At inclusion, at 4 years post-delivery and during the delivery stay
Arbovirosis Cohort: Detection of viral RNA by qualitative or semi-quantitative PCR in the placenta and amniotic fluid
Time frame: At delivery
Arbovirosis Cohort: Detection of viral RNA by qualitative or semi-quantitative PCR in breast milk in breast-feeding women with history of symptomatic, virologically confirmed arbovirus infection during pregnancy,
Time frame: At day 1, day 7 and day 30 after delivery
Arbovirosis Cohort: Prevalence of major congenital malformations; Arbovirus infection; Autism spectrum disorders;Confirmed arbovirus infection/hospitalization related to maternal/infant arbovirosis;Disorders; hospitalizations, chronic illness, death
The prevalence will be estimated for: * Major congenital malformations according to the EUROCAT classification diagnosed in the first 3 months of life; * Arbovirus infection confirmed at birth defined by detection of arbovirus by PCR in blood at birth; * Autism spectrum disorders at 18-24 months of age, evaluated by using the Modified Checklist Autism for Toddlers (M-CHAT); * Confirmed arbovirus infection and/or hospitalization related to maternal and/or infant arbovirosis during the first 24 months of life; * Disorders of (i) the gross and fine motor skills, assessed by using the "little Developmental Coordination Disorder Questionnaire-French European" (little DCDQ-FE) and (ii) the socioemotional development assessed by using the "Strengths \& Difficulties questionnaire" (SDQ) at 4 years of age. * Hospitalizations, late-onset congenital malformations (cardiac or cerebral), chronic illnesses and death occurring during the child's first 7 years of life, identified using data from PMSI
Time frame: From enrollement of children to the age of 7 years old
Arbovirosis Cohort: Clinical progression of the disease in infected children diagnosed with an arbovirus infection at birth,
Clinical progression of the disease will be characterised by symptoms, their severity and duration
Time frame: First 30 days of children life
Arbovirosis Cohort: Plasma viremia progression in infected children diagnosed with an arbovirus infection at birth
Plasma viremia progression will be measured by specific RT-PCR
Time frame: At day 1, day 7 and day 30 of life
Arbovirosis Cohort: Presence of total and neutralising antibodies against the arbovirus in the blood, in infected children diagnosed with an arbovirus infection at birth
Time frame: At day 1, day 7 and day 30 of life
Arbovirosis Cohort: Presence of total and neutralising antibodies against the arbovirus in the blood in breast-fed children not infected at birth
Time frame: At day 1, day 7 and day 30 of life
Arbovirosis Cohort: Confirmed arbovirus infection in breast-fed children not infected at birth
Confirmed arbovirus infection will be defined by detection of arbovirus by PCR in blood
Time frame: During breastfeeding, at day 7 and day 30 of life
Plan to share: Undecided
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