Centre de Méthodologie et de Gestion de Bichat
Paris, 75018, France
NCT Number: NCT07412977
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Paris, 75018, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Pregnant women :
Newborns/children:
Exclusion criteria
Pregnant women :
Newborns/children:
Blood sampling will be done to perform pharmacological and virological analysis.
Umbilical cord blood will be sampled to perform pharmacological analysis.
Questionnaires will be administered to the participant at different times during the study.
If breastfeeding, breast milk will be collected to perform pharmacological analysis.
Amniotic fluid will be sampled for virological and immunological analysis and biobanquing
Urine will be sampled for biobanquing
Vaginal swab will be sampled for biobanquing
Placenta will be sampled for virological and immunological analysis
Time frame: From enrollment to the end of follow-up at the age of 4
Time frame: From enrollment of the child to 9 months of age
Time frame: From enrollment of the child to between 18 and 24 months of age
Time frame: From enrollment up to 28 days of newborn's life
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:
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
Time frame: From enrollement of children to the age of 2 years old
Time frame: From enrollment of pregnant women to delivery
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.
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: Delivery stay
Quality of life will be assessed by the WHOQOL-BREF during the delivery stay
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.
Time frame: During the delivery stay and during the telephone visit at child's 4 years old
Time frame: During the delivery stay and during the telephone visit at child's 4 years of age
Time frame: Delivery stay
Presence of anxiety-depressive symptoms using the EPDS questionnaire
Time frame: From enrollment of pregnant women to delivery
Time frame: During the breast-feeding period, up to 24 months after delivery
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...)
Time frame: During the breast-feeding
Time frame: During the breast-feeding
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: At inclusion and at delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: During the post-partum period, up to 2 months after delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women to delivery
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
Time frame: During the delivery stay
Time frame: During the delivery stay
Time frame: During the delivery stay
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollement of children to the age of 2 years old
Time frame: From birth to the age of 2 years old
Time frame: During the follow-up period, up to 2 months after delivery
Time frame: 9 months after delivery
Time frame: From enrollement of children to the age of 7 years old
Time frame: 9 months after delivery
Time frame: At inclusion
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women up to 2 months after delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: During the post-partum period, up to 2 months after delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women to delivery
Time frame: During the delivery stay
Time frame: During the delivery stay
Time frame: At 3 months of age
Time frame: At child's 3months and 18-24 months
Time frame: At child's 9 months and 18-24 months
Time frame: From enrollement of children to the age of 7 years old
Time frame: From enrollment of pregnant women to delivery
Time frame: From enrollment of pregnant women to delivery
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
Time frame: At inclusion, at 4 years post-delivery and during the delivery stay
Time frame: At delivery
Time frame: At day 1, day 7 and day 30 after delivery
Time frame: From enrollement of children to the age of 7 years old
The prevalence will be estimated for:
Time frame: First 30 days of children life
Clinical progression of the disease will be characterised by symptoms, their severity and duration
Time frame: At day 1, day 7 and day 30 of life
Plasma viremia progression will be measured by specific RT-PCR
Time frame: At day 1, day 7 and day 30 of life
Time frame: At day 1, day 7 and day 30 of life
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
ANRS, Emerging Infectious Diseases
Other Gov
"Pregnancy and Viral Infections: Impact on Pregnant Women and Their Children. French Prospective Cohort."
Acronym: VIROPREG
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.
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