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

NCT07412977 | Not Yet Recruiting

• 1 other identifier: ANRS0288s VIROPREG
• Study Type: observational
• Target: 5,160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pregnancy; HIV; HBV; HCV; Arbovirus; National health data system; Neurocognitive disorders; Quality of life; Pregnancy viral infections; Mother-to-child transmission; Social epidemiology; Hepatitis

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (63)

• 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

Study Arms (4)

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.

Biological: Blood sampling; Biological: Umbilical cord blood sampling; Other: Survey using a questionnaire; Biological: Breast milk sampling

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.

Biological: Blood sampling; Other: Survey using a questionnaire

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.

Biological: Blood sampling; Other: Survey using a questionnaire

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.

Biological: Blood sampling; Biological: Umbilical cord blood sampling; Other: Survey using a questionnaire; Biological: Breast milk sampling; Biological: Amniotic fluid sampling; Biological: Urine sampling; Biological: Vaginal swab; Biological: Placenta sampling

Interventions

Blood sampling BIOLOGICAL

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

Arbovirus Cohort; HBV Cohort; HCV Cohort; HIV-1/HIV-2 Cohort

Umbilical cord blood sampling BIOLOGICAL

Umbilical cord blood will be sampled to perform pharmacological analysis.

Arbovirus Cohort; HIV-1/HIV-2 Cohort

Survey using a questionnaire OTHER

Questionnaires will be administered to the participant at different times during the study.

Arbovirus Cohort; HBV Cohort; HCV Cohort; HIV-1/HIV-2 Cohort

Breast milk sampling BIOLOGICAL

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

Arbovirus Cohort; HIV-1/HIV-2 Cohort

Amniotic fluid sampling BIOLOGICAL

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

Arbovirus Cohort

Urine sampling BIOLOGICAL

Urine will be sampled for biobanquing

Arbovirus Cohort

Vaginal swab BIOLOGICAL

Vaginal swab will be sampled for biobanquing

Arbovirus Cohort

Placenta sampling BIOLOGICAL

Placenta will be sampled for virological and immunological analysis

Arbovirus Cohort

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cis-gender female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women living with either HIV and/or HBV and/or HCV and/or Arbovirus will be enrolled in the study. After delivery, their child/children will also be enrolled.

You may qualify if:

• Pregnant women :
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (1)

Centre de Méthodologie et de Gestion de Bichat

Paris, 75018, France

Location

MeSH Terms

Conditions

HIV Infections; Hepatitis C; Arbovirus Infections; Neurocognitive Disorders; Hepatitis

Interventions

Blood Specimen Collection; Cordocentesis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Liver Diseases; Digestive System Diseases; Vector Borne Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Paracentesis; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2039
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)