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.
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;
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
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.
Cohort
Prospective
Blood sampling
Biological/VaccineBlood sampling will be done to perform pharmacological and virological analysis.
Umbilical cord blood sampling
Biological/VaccineUmbilical cord blood will be sampled to perform pharmacological analysis.
Survey using a questionnaire
Other interventionQuestionnaires will be administered to the participant at different times during the study.
Breast milk sampling
Biological/VaccineIf breastfeeding, breast milk will be collected to perform pharmacological analysis.
Amniotic fluid sampling
Biological/VaccineAmniotic fluid will be sampled for virological and immunological analysis and biobanquing
Urine sampling
Biological/VaccineUrine will be sampled for biobanquing
Vaginal swab
Biological/VaccineVaginal swab will be sampled for biobanquing
Placenta sampling
Biological/VaccinePlacenta 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
Hepatitis B Cohort: HBV infection at 9 months of age
Hepatitis C Cohort: HCV infection 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
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
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
HIV-1/HIV-2 cohort : Post-natal antiretroviral prophylaxis in children born to mothers living with HIV-1/HIV-2
HIV-1/HIV-2 Cohort: Obstetrical pathologies, hospitalizations and adverse pregnancy outcomes in pregnant women living with HIV-1/HIV-2
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