"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort."
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,160
- 试验地点
- 1
- 主要终点
- HIV-1/HIV-2 Cohort: Scores assessing gross and fine motor skills and social-emotional development at 4 years of age
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
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.
干预措施: Blood sampling (Biological)
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.
干预措施: Umbilical cord blood sampling (Biological)
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.
干预措施: Survey using a questionnaire (Other)
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.
干预措施: Breast milk sampling (Biological)
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.
干预措施: Blood sampling (Biological)
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.
干预措施: Survey using a questionnaire (Other)
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.
干预措施: Blood sampling (Biological)
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.
干预措施: Survey using a questionnaire (Other)
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.
干预措施: Blood sampling (Biological)
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.
干预措施: Umbilical cord blood sampling (Biological)
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.
干预措施: Survey using a questionnaire (Other)
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.
干预措施: Breast milk sampling (Biological)
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.
干预措施: Amniotic fluid sampling (Biological)
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.
干预措施: Urine sampling (Biological)
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.
干预措施: Vaginal swab (Biological)
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.
干预措施: Placenta sampling (Biological)
结局指标
主要结局
HIV-1/HIV-2 Cohort: Scores assessing gross and fine motor skills and social-emotional development at 4 years of age
时间窗: From enrollment to the end of follow-up at the age of 4
Hepatitis B Cohort: HBV infection at 9 months of age
时间窗: From enrollment of the child to 9 months of age
Hepatitis C Cohort: HCV infection between 18 and 24 months of age
时间窗: 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
时间窗: From enrollment up to 28 days of newborn's life
次要结局
- 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(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(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(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(Delivery stay)
- HIV-1/HIV-2 Cohort: Adherence of women in pregnant women living with HIV-1/HIV-2(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(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(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(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(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(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,(First 30 days of children life)
- Arbovirosis Cohort: Plasma viremia progression 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 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(During breastfeeding, at day 7 and day 30 of life)