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

Centre Hospitalier Universitaire Saint Pierre

Status: Terminated

Conditions: Covid-19; Pregnancy

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04432779

Elikya Covid

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,362 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,362 participants in 4 patient groups

Women tested positive to SARS-CoV-2 during pregnancy

Description:

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.

Treatment:

Other: no intervention

Women tested negative to SARS-CoV-2 during pregnancy

Description:

All women who had a positive nasal swab or a positive serology during pregnancy or at delivery are included. No follow up after delivery.

Treatment:

Other: no intervention

Newborns from women tested positive

Description:

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.

Treatment:

Other: no intervention

Newborns from women tested negative

Description:

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.

Treatment:

Other: no intervention