Understanding COVID-19 Infection in Pregnant Women and Their Babies

Completed

• Conditions: Corona Virus Infection; Pregnancy Related; Neonatal Infection; Breastfeeding

• Registration Number: NCT04703270
• Lead Sponsor: St George's, University of London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-04
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Primary Completion: 2022-04-30
• Status Verified: 2022-05
• Study Completion: 2023-09-30
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 867

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody concentrations in maternal and cord blood in pregnant women in England and in infant blood if mothers are rtPCR positive for SARS-COV-2	12 months

Secondary Outcome Measures

Name	Time	Method
Placental samples that are rtPCR positive	At birth
Breastmilk samples that are rtPCR positive	At birth and 6 weeks postpartum
Mother-infant pairs who are both rtPCR positive in blood or secretions at birth	At birth
Antibodies specific to SARS-CoV-2 in breastmilk	At birth and 6 weeks postpartum
Placental samples in whom the virus can be grown in vitro	At birth
Breastmilk samples in whom the virus can be grown in vitro.	At birth and 6 weeks postpartum
Mother-infant pairs at six weeks in whom the virus can be grown in vitro	At 6 weeks postpartum

Trial Locations

Locations (1)

St George's, University of London; 🇬🇧 London, United Kingdom