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periCOVID: Understanding COVID-19 Infection in Pregnant Women and Their Babies

Sponsor
St George's, University of London (Other)
Overall Status
Recruiting
CT.gov ID
NCT04703270
Collaborator
(none)
1,200
Enrollment
1
Location
24
Anticipated Duration (Months)
50.1
Patients Per Site Per Month

Study Details

Study Description

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 UK, the prevalence of vertical transmission of the virus or antibodies against the virus, and the effect, if any, on neonatal outcomes.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Understanding COVID-19 Infection in Pregnant Women and Their Babies
    Actual Study Start Date :
    Jan 4, 2021
    Anticipated Primary Completion Date :
    Jan 3, 2023
    Anticipated Study Completion Date :
    Jan 3, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Antibodies specific to SARS-CoV-2 in breastmilk [At birth and 6 weeks postpartum]

    2. Mother-infant pairs who are both rtPCR positive in blood or secretions at birth [At birth]

    3. Breastmilk samples that are rtPCR positive [At birth and 6 weeks postpartum]

    4. Placental samples that are rtPCR positive [At birth]

    5. Placental samples in whom the virus can be grown in vitro [At birth]

    6. Breastmilk samples in whom the virus can be grown in vitro. [At birth and 6 weeks postpartum]

    7. Mother-infant pairs at six weeks in whom the virus can be grown in vitro [At 6 weeks postpartum]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St George's, University of London London United Kingdom SW17 0RE

    Sponsors and Collaborators

    • St George's, University of London

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St George's, University of London
    ClinicalTrials.gov Identifier:
    NCT04703270
    Other Study ID Numbers:
    • 2020.0276
    First Posted:
    Jan 11, 2021
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Coronavirus Infections

    Study Results

    No Results Posted as of Jan 11, 2021