Pregnancy Related Clinical Trial
— periCOVIDOfficial title:
Understanding COVID-19 Infection in Pregnant Women and Their Babies
Verified date | May 2022 |
Source | St George's, University of London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | St George's, University of London | London |
Lead Sponsor | Collaborator |
---|---|
St George's, University of London |
United Kingdom,
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 |
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