"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort" (VIROPREG)

"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort."

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:

• 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.

Study Overview

• Status: Not yet recruiting
• Conditions: HIV Infection; Arbovirus Infections; HCV Infection; HDV Infection; HBV Infection
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Estimated): 5160

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Centre de Méthodologie et de Gestion de Bichat
    • Contact: Project Manager; Phone Number: 01 40 25 70 41; Email: viropreg.anrs@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: Blood sampling; Blood sampling will be done to perform pharmacological and virological analysis.; Biological: Umbilical cord blood sampling; Umbilical cord blood will be sampled to perform pharmacological analysis.; Other: Survey using a questionnaire; Questionnaires will be administered to the participant at different times during the study.; Biological: Breast milk sampling; If breastfeeding, breast milk will be collected to perform pharmacological analysis.
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.	Biological: Blood sampling; Blood sampling will be done to perform pharmacological and virological analysis.; Other: Survey using a questionnaire; Questionnaires will be administered to the participant at different times during the study.
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.	Biological: Blood sampling; Blood sampling will be done to perform pharmacological and virological analysis.; Other: Survey using a questionnaire; Questionnaires will be administered to the participant at different times during the study.
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.	Biological: Blood sampling; Blood sampling will be done to perform pharmacological and virological analysis.; Biological: Umbilical cord blood sampling; Umbilical cord blood will be sampled to perform pharmacological analysis.; Other: Survey using a questionnaire; Questionnaires will be administered to the participant at different times during the study.; Biological: Breast milk sampling; If breastfeeding, breast milk will be collected to perform pharmacological analysis.; Biological: Amniotic fluid sampling; Amniotic fluid will be sampled for virological and immunological analysis and biobanquing; Biological: Urine sampling; Urine will be sampled for biobanquing; Biological: Vaginal swab; Vaginal swab will be sampled for biobanquing; Biological: Placenta sampling; Placenta will be sampled for virological and immunological analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HIV-1/HIV-2 Cohort: Scores assessing gross and fine motor skills and social-emotional development at 4 years of age	From enrollment to the end of follow-up at the age of 4
Hepatitis B Cohort: HBV infection at 9 months of age	From enrollment of the child to 9 months of age
Hepatitis C Cohort: HCV infection between 18 and 24 months of age	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	From enrollment up to 28 days of newborn's life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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		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		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.	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		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		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	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.	Delivery stay
HIV-1/HIV-2 Cohort: Experienced discrimination and care-giver interactions in pregnant women living with HIV-1/HIV-2		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		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	Delivery stay
HIV-1/HIV-2 Cohort: Non-optimal access to care during pregnancy; comparison of care consumption with HAS recommendations for pregnancy monitoring		From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Breast-feeding practices: in the event of breast-feeding		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...)	From enrollment of pregnant women to delivery
HIV-1/HIV-2 Cohort: Monthly measurements of ARV drug concentration in breast milk (if breast-feeding)		During the breast-feeding
HIV-1/HIV-2 Cohort: In breast-fed newborns, monthly measurements of plasma concentrations of the same ARVs		During the breast-feeding
HBV Cohort: Delay between diagnosis of HBV infection and date of onset of pregnancy in HBV-infected pregnant women		From enrollment of pregnant women to delivery
HBV Cohort: Therapeutic prophylaxis practices in HBV-infected pregnant women		From enrollment of pregnant women to delivery
HBV Cohort: HBV viral load during obstetrical follow-up and at delivery in HBV-infected pregnant women		From enrollment of pregnant women to delivery
HBV Cohort: Plasma concentrations of HBV antivirals in treated women		At inclusion and at delivery
HBV Cohort: Maternal morbidity and mortality		From enrollment of pregnant women to delivery
HBV Cohort: Initiation or resumption of follow-up by a hepatologist of postpartum HBV-infected women		During the post-partum period, up to 2 months after delivery
HBV Cohort: Screening practices among close contacts of infected women		From enrollment of pregnant women to delivery
HBV Cohort: Seroprevalence of HDV in HBV-infected pregnant women		From enrollment of pregnant women to delivery
HBV Cohort: Active HDV infection (in women with positive HDV serology)		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)		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	At inclusion and during the delivery stay
HBV Cohort: Adherence of HBV-infected pregnant women		During the delivery stay
HBV Cohort: Presence of anxiety-depressive symptoms in women living with HBV		During the delivery stay
HBV Cohort: Experienced discrimination and care-giver interactions in HBV-infected pregnant women		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		From enrollment of pregnant women to delivery
HBV Cohort: Post-natal serovaccination of children and schedule		From enrollement of children to the age of 2 years old
HBV Cohort: HBV infection in children born to HBV-infected mothers		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)		During the follow-up period, up to 2 months after delivery
HBV Cohort: Timing of mother-to-child transmission in HBV-infected children		9 months after delivery
HBV Cohort: Hospitalizations and chronic illnesses		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		9 months after delivery
HCV Cohort: Socio-demographic profile of infected women		At inclusion
HCV Cohort: Maternal morbidity and mortality events in HCV-infected pregnant women		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)		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		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		During the post-partum period, up to 2 months after delivery
HCV Cohort: HCV antiviral treatment during pregnancy		From enrollment of pregnant women to delivery
HCV Cohort: Plasma concentrations of antivirals during pregnancy in women receiving HCV treatment		From enrollment of pregnant women to delivery
HCV Cohort: Adherence of HCV-infected pregnant women		During the delivery stay
HCV Cohort: Presence of anxiety-depressive symptoms in women living with HCV		During the delivery stay
HCV Cohort: Active HCV infection in children born to HCV-infected mothers		At 3 months of age
HCV Cohort: Diagnostic performance of PCR at 3 months between 18 and 24 months of age		At child's 3months and 18-24 months
HCV Cohort: Spontaneous cure rate at 9 months and between 18 and 24 months of age		At child's 9 months and 18-24 months
HCV Cohort: Morbidity criteria in the first 7 years of life		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		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		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	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		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		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,		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	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	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	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		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		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	During breastfeeding, at day 7 and day 30 of life

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2039

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: HIV; Pregnancy; Quality of life; HCV; Hepatitis; HBV; Mother-to-child transmission; Arbovirus; Neurocognitive disorders; National health data system; Pregnancy viral infections; Social epidemiology
• Additional Relevant MeSH Terms: Blood-Borne Infections; Vector Borne Diseases; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Flaviviridae Infections; Hepatitis; HIV Infections; Neurocognitive Disorders; Hepatitis C; Arbovirus Infections; Investigative Techniques; Therapeutics; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection; Cordocentesis
• Other Study ID Numbers: ANRS0288s VIROPREG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No