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

Terminated

• Conditions: Pregnancy; Covid-19

• Registration Number: NCT04432779
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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.

Study Timeline

• Study Start: 2020-05-25
• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-15
• Study First Posted: 2020-06-16
• Primary Completion: 2020-10-06
• Study Completion: 2022-03-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1362

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Outcome of pregnancy	Up to the delivery	Incidence of miscarriage, premature delivery, low birth weight, preeclampsia, chorioamnionitis

Secondary Outcome Measures

Name	Time	Method
Prevalence of positive serology to SARS-CoV-2 at delivery	At the delivery	Measure of antibodies in maternal serum at 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	Up to 1 month post delivery	Measure of antibodies in cord blood and at the age of 1 month
Clinical evolution of the children	Up to 3 years	Occurence of infectious disease, neurological development, growth
To characterize placental alterations related to SARS-CoV-2 infection	At the delivery	Placental histology will be performed in women tested positive for SARS-CoV-2 during pregnancy
Transplacental transfer of antibodies to SARS-CoV-2	At the delivery	Measure the ratio of cord blood antibodies on maternal antibodies titers

Trial Locations

Locations (1)

CHU SAINT Pierre; 🇧🇪 Brussels, Belgium