Understanding COVID-19 Infection in Pregnant Women and Their Babies

NCT04703270 | Completed Results

• 1 other identifier: 2020.0276
• Study Type: observational
• Target: 881
• Locations: 1 country
• Sites: 1

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.

Conditions

Corona Virus Infection; Pregnancy Related; Neonatal Infection; Breastfeeding

Outcome Measures

Primary Outcomes (2)

• Antibody Concentrations in Maternal Blood in Pregnant Women in England

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

  Delivery

• Antibody Concentrations in Cord/Infant Blood at 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.

  Delivery

Secondary Outcomes (8)

• 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

Study Arms (3)

Exposed

Expectant mothers with a positive nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation regardless of antibody status.

Seropositive

Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation but positive IgM/IgG antibodies against SARS-CoV-2.

Unexposed

Expectant mothers with a negative nasopharyngeal swab for SARS-CoV-2 at any point during pregnancy from 24 weeks gestation and negative IgM/IgG antibodies against SARS-CoV-2.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women ≥ 24 weeks gestation in England.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

St George's, University of London

London, SW17 0RE, United Kingdom

Location

MeSH Terms

Conditions

Coronavirus Infections; Breast Feeding

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Feeding Behavior; Behavior

Results Point of Contact

• Title: Dr Sarah Sturrock
• Organization: St George's, University of London

ssturroc@sgul.ac.uk

020 8672 9944

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: January 4, 2021
• Primary Completion: April 30, 2022
• Study Completion: September 30, 2023
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)