An observational study in Pregnancy and Covid-19, sponsored by Centre Hospitalier Universitaire Saint Pierre. Terminated at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Centre Hospitalier Universitaire Saint Pierre · Observational
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.
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.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 1,362 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Centre Hospitalier Universitaire Saint Pierre is the lead sponsor of 78 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All women who deliver in the CHU St Pierre and children born to positive mothers and controls matched on gestational age and ethnicity
Exclusion Criteria:
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
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
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
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
no intervention
Outcome of pregnancy
Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis
Time frame: Up to the delivery
Prevalence of positive serology to SARS-CoV-2 at delivery
Measure of antibodies in maternal serum at delivery
Time frame: At the delivery
Transplacental transfer of antibodies to SARS-CoV-2
Measure the ratio of cord blood antibodies on maternal antibodies titers
Time frame: 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
Time frame: At the delivery
Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothers
Time frame: 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
Time frame: Up to 1 month post delivery
Clinical evolution of the children
Occurence of infectious disease, neurological development, growth
Time frame: Up to 3 years
Plan to share: No
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Universitaire Saint Pierre