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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Corona Virus Infection; Breastfeeding; Neonatal Infection

• Study Type: Observational
• Enrollment (Actual): 881

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 0RE
    • St George's, University of London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All pregnant women ≥ 24 weeks gestation in England.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2	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
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

Collaborators and Investigators

• Sponsor: St George's, University of London

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; RNA Virus Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; Infections; Communicable Diseases; Coronavirus Infections
• Other Study ID Numbers: 2020.0276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No