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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Biological | Blood sampling will be done to perform pharmacological and virological analysis. |
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| Measure | Description | 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 |
| 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:
|
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Inclusion Criteria:
Pregnant women :
Newborns/children:
- Free, informed, written and signed consent of parental guardians.
Exclusion Criteria:
Pregnant women :
Newborns/children:
Cis-gender female
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Méthodologie et de Gestion de Bichat | Paris | 75018 | France |
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| Umbilical cord blood sampling | Biological | Umbilical cord blood will be sampled to perform pharmacological analysis. |
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| Survey using a questionnaire | Other | Questionnaires will be administered to the participant at different times during the study. |
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| Breast milk sampling | Biological | If breastfeeding, breast milk will be collected to perform pharmacological analysis. |
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| Amniotic fluid sampling | Biological | Amniotic fluid will be sampled for virological and immunological analysis and biobanquing |
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| Urine sampling | Biological | Urine will be sampled for biobanquing |
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| Vaginal swab | Biological | Vaginal swab will be sampled for biobanquing |
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| Placenta sampling | Biological | Placenta will be sampled for virological and immunological analysis |
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| 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:
| 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 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006526 | Hepatitis C |
| D001102 | Arbovirus Infections |
| D019965 | Neurocognitive Disorders |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D018178 | Flaviviridae Infections |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000079426 | Vector Borne Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D017218 | Cordocentesis |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D019152 | Paracentesis |
| D013812 | Therapeutics |
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