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

Official title

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

Overview

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.

Interventions

• Biological Blood sampling
  Blood sampling will be done to perform pharmacological and virological analysis.
• Biological Umbilical cord blood sampling
  Umbilical cord blood will be sampled to perform pharmacological analysis.
• Other Survey using a questionnaire
  Questionnaires will be administered to the participant at different times during the study.
• Biological Breast milk sampling
  If breastfeeding, breast milk will be collected to perform pharmacological analysis.
• Biological Amniotic fluid sampling
  Amniotic fluid will be sampled for virological and immunological analysis and biobanquing
• Biological Urine sampling
  Urine will be sampled for biobanquing
• Biological Vaginal swab
  Vaginal swab will be sampled for biobanquing
• Biological Placenta sampling
  Placenta will be sampled for virological and immunological analysis

Primary outcome measures

• 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]
• Hepatitis B Cohort: HBV infection at 9 months of age [Time frame: From enrollment of the child to 9 months of age]
• 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]
• 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 outcome measures (12)

• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• HIV-1/HIV-2 Cohort: Quality of life in pregnant women living with HIV-1/HIV-2 [Time frame: Delivery stay]
• HIV-1/HIV-2 Cohort: Adherence of women in pregnant women living with HIV-1/HIV-2 [Time frame: Delivery stay]
• 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]
• 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]
• HIV-1/HIV-2 Cohort: Presence of anxiety-depressive symptoms in pregnant women living with HIV-1/HIV-2 [Time frame: Delivery stay]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Centre de Méthodologie et de Gestion de Bichat — Paris

Identifiers

NCT: NCT07412977 · ANRS0288s VIROPREG

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗