Understanding COVID-19 Infection in Pregnant Women and Their Babies

St George's, University of London1 site in 1 country881 target enrollmentJanuary 4, 2021

ConditionsCorona Virus Infection Pregnancy Related Neonatal Infection Breastfeeding

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Corona Virus Infection
Sponsor: St George's, University of London
Enrollment: 881
Locations: 1
Primary Endpoint: Antibody Concentrations in Maternal Blood in Pregnant Women in England
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.

Registry

clinicaltrials.gov

Start Date

January 4, 2021

End Date

September 30, 2023

Last Updated

10 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

St George's, University of London

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed informed consent form
•Any woman pregnant in selected hospitals in England who has no signs or symptoms of COVID-19 disease during pregnancy and is rtPCR negative at delivery
•Any woman pregnant in any hospital in England who tests positive by rtPCR at any point during pregnancy from 24 weeks gestation onwards, regardless of signs and symptoms

Exclusion Criteria

•If the pregnant woman is under 18 years in prison or unable to make an informed consent for other reasons (e.g. learning difficulties, language barriers)

Outcomes

Primary Outcomes

Antibody Concentrations in Maternal Blood in Pregnant Women in England

Time Frame: Delivery

Antibody concentrations in maternal blood in pregnant women in England: ADCD-S values reported

Antibody Concentrations in Cord/Infant Blood at Delivery

Time Frame: Delivery

Cord blood was tested to determine infant antibody levels; where a cord blood sample was not available, a blood sample was taken from the infant instead. ADCD-S assay results are presented.

Secondary Outcomes

Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2(At birth)
Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery(Delivery)
Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery(Delivery)
Breastmilk Samples That Are rtPCR Positive(Delivery)
Placental Samples That Are rtPCR Positive(Delivery)
Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro(Delivery)
Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro(Delivery)
Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro(6 weeks post delivery)