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

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.

Conditions

• HIV Infection
• HBV Infection
• HDV Infection
• HCV Infection
• Arbovirus Infections

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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases

  lead OTHER_GOV

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-28

Primary Completion

2033-12-31

Completion

2039-12-31

Countries

• France

Study Locations