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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04432779
Acronym
ELIKYA COVID
Enrollment
1362
Registered
2020-06-16
Start date
2020-05-25
Completion date
2022-03-01
Last updated
2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid-19, Pregnancy

Keywords

Covid-19, Pregnancy, antibodies, congenital SARS infection, breast milk

Brief summary

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

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Institute for Medical Immunology (IMI)
CollaboratorUNKNOWN
Laboratoire Hospitalier Universitaire de Bruxelles (LHUB)
CollaboratorUNKNOWN
Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Outcome of pregnancyUp to the deliveryIncidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis

Secondary

MeasureTime frameDescription
Transplacental transfer of antibodies to SARS-CoV-2At the deliveryMeasure the ratio of cord blood antibodies on maternal antibodies titers
To characterize placental alterations related to SARS-CoV-2 infectionAt the deliveryPlacental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy
Prevalence of positive serology to SARS-CoV-2 at deliveryAt the deliveryMeasure of antibodies in maternal serum at delivery
To characterize the immunity transmitted to the newborn to cord blood and its persistence at the age of 1 month of lifeUp to 1 month post deliveryMeasure of antibodies in cord blood and at the age of 1 month
Clinical evolution of the childrenUp to 3 yearsOccurence of infectious disease, neurological development, growth
Presence of maternal antibodies to SARS-CoV-2 in breast milk in breastfeeding mothersAt 1 month post delivery

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026