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OpenTrials
Completed

NCT Number: NCT04703270

Understanding COVID-19 Infection in Pregnant Women and Their Babies

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.

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Key information

Conditions

Corona Virus Infection Behavior Breast Feeding Breastfeeding Coronaviridae Infections Coronavirus Infections Feeding Behavior Infections Neonatal Infection Nidovirales Infections Pregnancy Related RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

St George's, University of London

London, SW17 0RE, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Antibody Concentrations in Maternal Blood in Pregnant Women in England

    Time frame: Delivery

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

  2. Antibody Concentrations in Cord/Infant Blood at Delivery

    Time frame: 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 outcomes

  1. Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2

    Time frame: At birth

    Number of participants with breastmilk samples positive for antibodies specific to SARS-CoV-2

  2. Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery

    Time frame: Delivery

  3. Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery

    Time frame: Delivery

  4. Breastmilk Samples That Are rtPCR Positive

    Time frame: Delivery

  5. Placental Samples That Are rtPCR Positive

    Time frame: Delivery

  6. Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro

    Time frame: Delivery

  7. Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro

    Time frame: Delivery

  8. Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro

    Time frame: 6 weeks post delivery

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Registry information

Acronym: periCOVID

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 11, 2021
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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