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
• Study Completion: 2023-09-30
• Status Verified: 2024-08
• Results First Submitted: 2024-08-06
• Results First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Results First Posted: 2025-06-18
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 881

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 Blood in Pregnant Women in England	Delivery	Antibody concentrations in maternal blood in pregnant women in England: ADCD-S values reported
Antibody Concentrations in Cord/Infant Blood at Delivery	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 Outcome Measures

Name	Time	Method
Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2	At birth	Number of participants with breastmilk samples positive for antibodies specific to SARS-CoV-2
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

Trial Locations

Locations (1)

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