Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07412977

"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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Blood sampling

Biological

Blood sampling will be done to perform pharmacological and virological analysis.

Umbilical cord blood sampling

Biological

Umbilical cord blood will be sampled to perform pharmacological analysis.

Survey using a questionnaire

Other

Questionnaires will be administered to the participant at different times during the study.

Breast milk sampling

Biological

If breastfeeding, breast milk will be collected to perform pharmacological analysis.

Amniotic fluid sampling

Biological

Amniotic fluid will be sampled for virological and immunological analysis and biobanquing

Urine sampling

Biological

Urine will be sampled for biobanquing

Vaginal swab

Biological

Vaginal swab will be sampled for biobanquing

Placenta sampling

Biological

Placenta will be sampled for virological and immunological analysis

Primary outcomes

  1. 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

  2. Hepatitis B Cohort: HBV infection at 9 months of age

    Time frame: From enrollment of the child to 9 months of age

  3. 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

  4. 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

Secondary outcomes

  1. 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

    Time frame: From enrollement of children to the age of 7 years old

    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
  2. HIV-1/HIV-2 cohort : Social determinants in children born to mothers living with HIV-1/HIV-2

    Time frame: From enrollment of the children to the age of 7 years old

    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

  3. 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

  4. 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

  5. HIV-1/HIV-2 Cohort: Social determinants in pregnant women living with HIV-1/HIV-2

    Time frame: From enrollment of pregnant women up to the children's 7 years old

    Social determinants will be collected using the SDI and the augmented PRECAR score.

  6. 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

  7. 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

  8. HIV-1/HIV-2 Cohort: Quality of life in pregnant women living with HIV-1/HIV-2

    Time frame: Delivery stay

    Quality of life will be assessed by the WHOQOL-BREF during the delivery stay

  9. HIV-1/HIV-2 Cohort: Adherence of women in pregnant women living with HIV-1/HIV-2

    Time frame: Delivery stay

    Adherence of women will be assessed through HIV-related literacy with the FCCHL (Functional, Communicative and Critical Health Literacy scale) during the delivery stay.

  10. 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

  11. 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

  12. HIV-1/HIV-2 Cohort: Presence of anxiety-depressive symptoms in pregnant women living with HIV-1/HIV-2

    Time frame: Delivery stay

    Presence of anxiety-depressive symptoms using the EPDS questionnaire

  13. 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

  14. 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

  15. HIV-1/HIV-2 Cohort: Measurement of drug concentration in plasma in pregnant women treated with certains targeted drugs

    Time frame: From enrollment of pregnant women to delivery

    Targeted drugs are: tenofovir alafenamide, etravirine, doravirine, rilpivirine, bictegravir,dolutegravir, cabotegravir, raltegravir, fostemsavir, lenacapavir, any new ARV not yet marketed in 2023 (islatravir, ibalizumab...)

  16. HIV-1/HIV-2 Cohort: Monthly measurements of ARV drug concentration in breast milk (if breast-feeding)

    Time frame: During the breast-feeding

  17. HIV-1/HIV-2 Cohort: In breast-fed newborns, monthly measurements of plasma concentrations of the same ARVs

    Time frame: During the breast-feeding

  18. 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

  19. HBV Cohort: Therapeutic prophylaxis practices in HBV-infected pregnant women

    Time frame: From enrollment of pregnant women to delivery

  20. 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

  21. HBV Cohort: Plasma concentrations of HBV antivirals in treated women

    Time frame: At inclusion and at delivery

  22. HBV Cohort: Maternal morbidity and mortality

    Time frame: From enrollment of pregnant women to delivery

  23. 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

  24. HBV Cohort: Screening practices among close contacts of infected women

    Time frame: From enrollment of pregnant women to delivery

  25. HBV Cohort: Seroprevalence of HDV in HBV-infected pregnant women

    Time frame: From enrollment of pregnant women to delivery

  26. HBV Cohort: Active HDV infection (in women with positive HDV serology)

    Time frame: From enrollment of pregnant women to delivery

  27. 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

  28. HBV Cohort: Social determinants in HBV-infected pregnant women

    Time frame: At inclusion and during the delivery stay

    Social determinants will be assessed by the social deprivation during pregnancy index (SDI) and the augmented PRECAR score

  29. HBV Cohort: Adherence of HBV-infected pregnant women

    Time frame: During the delivery stay

  30. HBV Cohort: Presence of anxiety-depressive symptoms in women living with HBV

    Time frame: During the delivery stay

  31. HBV Cohort: Experienced discrimination and care-giver interactions in HBV-infected pregnant women

    Time frame: During the delivery stay

  32. 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

  33. HBV Cohort: Post-natal serovaccination of children and schedule

    Time frame: From enrollement of children to the age of 2 years old

  34. HBV Cohort: HBV infection in children born to HBV-infected mothers

    Time frame: From birth to the age of 2 years old

  35. 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

  36. HBV Cohort: Timing of mother-to-child transmission in HBV-infected children

    Time frame: 9 months after delivery

  37. HBV Cohort: Hospitalizations and chronic illnesses

    Time frame: From enrollement of children to the age of 7 years old

  38. HBV Cohort: HDV infection in children born to mother co-infected with HBV/HDV

    Time frame: 9 months after delivery

  39. HCV Cohort: Socio-demographic profile of infected women

    Time frame: At inclusion

  40. HCV Cohort: Maternal morbidity and mortality events in HCV-infected pregnant women

    Time frame: From enrollment of pregnant women to delivery

  41. 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

  42. 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

  43. 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

  44. HCV Cohort: HCV antiviral treatment during pregnancy

    Time frame: From enrollment of pregnant women to delivery

  45. HCV Cohort: Plasma concentrations of antivirals during pregnancy in women receiving HCV treatment

    Time frame: From enrollment of pregnant women to delivery

  46. HCV Cohort: Adherence of HCV-infected pregnant women

    Time frame: During the delivery stay

  47. HCV Cohort: Presence of anxiety-depressive symptoms in women living with HCV

    Time frame: During the delivery stay

  48. HCV Cohort: Active HCV infection in children born to HCV-infected mothers

    Time frame: At 3 months of age

  49. 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

  50. 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

  51. HCV Cohort: Morbidity criteria in the first 7 years of life

    Time frame: From enrollement of children to the age of 7 years old

  52. 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

  53. 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

  54. Arbovirosis Cohort: Quality of life in pregnant women with symptomatic, virologically confirmed arbovirus infection

    Time frame: At day 1 and between day7-10 post-infection and during the delivery stay

    Quality of life will be assessed by the EuroQol-5 Dimension (EQ5D) and by the WHOQOL-BREF

  55. 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

  56. Arbovirosis Cohort: Detection of viral RNA by qualitative or semi-quantitative PCR in the placenta and amniotic fluid

    Time frame: At delivery

  57. 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

  58. 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

    Time frame: From enrollement of children to the age of 7 years old

    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
  59. Arbovirosis Cohort: Clinical progression of the disease in infected children diagnosed with an arbovirus infection at birth,

    Time frame: First 30 days of children life

    Clinical progression of the disease will be characterised by symptoms, their severity and duration

  60. Arbovirosis Cohort: Plasma viremia progression in infected children diagnosed with an arbovirus infection at birth

    Time frame: At day 1, day 7 and day 30 of life

    Plasma viremia progression will be measured by specific RT-PCR

  61. 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

  62. 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

  63. Arbovirosis Cohort: Confirmed arbovirus infection in breast-fed children not infected at birth

    Time frame: During breastfeeding, at day 7 and day 30 of life

    Confirmed arbovirus infection will be defined by detection of arbovirus by PCR in blood

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

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

Acronym: VIROPREG

Important dates

Study start
2026
Primary completion
2033
Study completion
2039
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.