Impact of COVID-19 Infection During Pregnancy on Newborns and Young Children

Study Overview
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Brief Summary
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This study aim is to assess impact of COVID-19 infection during pregnancy on outcome of pregnancy, and on developement of the child in early life.

Detailed Description
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All pregnant women will be tested for serology during each trimester of pregnancy and at delivery, together with a nasal swab. Children born to women with positive sawb or serology will be followed up for 3 years together with a control child born to negative mother. In positive mothers, maternal antibodies at delivery will be characterized, placental transfer will be assessed. Persistence of antibodies in children at the age of 1 month and presence of antibodies in breast milk will be measured. Occurence of premature birth, low birth weight, miscarriage, congenital malformations will be compared in positive and negative mothers. Follow up of children over the first 3 years of life will assess difference in susceptibility to infections and neurological developement in both groups.

Official Title
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Impact of SARS-CoV-2 Infection During Pregnancy on Newborns and Young Children

Conditions
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Pregnancy, Covid-19

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For pregnant women, all women who deliver in the CHU St Pierre, with oral consent. For children follow up: children born to positive mothers and matched controls after written consent Exclusion Criteria: none
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women tested positive to SARS-CoV-2 during pregnancy<br>All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included. Follow up end at 1 month post delivery. | Other: no intervention<br>* no intervention<br>|
| Women tested negative to SARS-CoV-2 during pregnancy<br>All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included. No follow up after delivery. | Other: no intervention<br>* no intervention<br>|
| Newborns from women tested positive<br>Newborns born to mothers who had a positive nasal swab or a positive serology during pregnancy or at delivery and who consented the follow up study. Follow up end at 3 years of age. | Other: no intervention<br>* no intervention<br>|
| Newborns from women tested negative<br>Newborns born to mothers who had no COVID-19 infection during pregnancy or at delivery and who consented the follow up study. These control children will be matched with children from the other group for gestational age and ethnicity. Follow up end at 3 years of age. | Other: no intervention<br>* no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of pregnancy | Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis | Up to the delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of positive serology to SARS-CoV-2 at delivery | Measure of antibodies in maternal serum at delivery | At the delivery | 
| Transplacental transfer of antibodies to SARS-CoV-2 | Measure the ratio of cord blood antibodies on maternal antibodies titers | At the delivery | 
| To characterize placental alterations related to SARS-CoV-2 infection | Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy | At the delivery | 
| Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers |  | At 1 month post delivery | 
| To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of life | Measure of antibodies in cord blood and at the age of 1 month | Up to 1 month post delivery | 
| Clinical evolution of the children | Occurence of infectious disease, neurological development, growth | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid-19, Pregnancy, antibodies, congenital SARS infection, breast milk