Understanding COVID-19 Infection in Pregnant Women and Their Babies

Pregnancy Related Clinical Trial

— periCOVID  

Official title:

Understanding COVID-19 Infection in Pregnant Women and Their Babies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703270
• Other study ID #: 2020.0276
• Status: Completed
• Start date: January 4, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: May 2022
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 867
• Est. completion date: September 30, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breastfeeding
• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Infections
• Neonatal Infection
• Pregnancy Related

Locations

Country	Name	City	State
United Kingdom	St George's, University of London	London

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antibodies specific to SARS-CoV-2 in breastmilk		At birth and 6 weeks postpartum
Secondary	Mother-infant pairs who are both rtPCR positive in blood or secretions at birth		At birth
Secondary	Breastmilk samples that are rtPCR positive		At birth and 6 weeks postpartum
Secondary	Placental samples that are rtPCR positive		At birth
Secondary	Placental samples in whom the virus can be grown in vitro		At birth
Secondary	Breastmilk samples in whom the virus can be grown in vitro.		At birth and 6 weeks postpartum
Secondary	Mother-infant pairs at six weeks in whom the virus can be grown in vitro		At 6 weeks postpartum