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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Umbilical cord blood sampling: Umbilical cord blood will be sampled to perform pharmacological analysis.

Survey using a questionnaire: Questionnaires will be administered to the participant at different times during the study.

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

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

Urine sampling: Urine will be sampled for biobanquing

Vaginal swab: Vaginal swab will be sampled for biobanquing

Placenta sampling: Placenta will be sampled for virological and immunological analysis

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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