Understanding COVID-19 Infection in Pregnant Women and Their Babies

NCT ID: NCT04703270

Last Updated: 2025-06-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

881 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-04

Study Completion Date

2023-09-30

Brief Summary

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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

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Conditions

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Corona Virus Infection Pregnancy Related Neonatal Infection Breastfeeding

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St George's, University of London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2020.0276

Identifier Type: -

Identifier Source: org_study_id

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