Corona Virus InfectionperiCOVIDNCT04703270
Understanding COVID-19 Infection in Pregnant Women and Their Babies
An observational study of Corona Virus Infection and Pregnancy Related, run by St George's, University of London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Corona Virus Infection, Pregnancy Related, Neonatal Infection
- How many people
- 881 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2021to 30 Sep 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pregnant women ≥ 24 weeks gestation in England.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's, University of London
London, SW17 0RE
About this study
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.
- Medical subject headings
- Coronavirus Infections, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Antibody Concentrations in Maternal Blood in Pregnant Women in England
Antibody concentrations in maternal blood in pregnant women in England: ADCD-S values reported
Measured: 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.
Measured: Delivery
Secondary outcomes (8)
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
Measured: At birth
Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery
Measured: Delivery
Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery
Measured: Delivery
Breastmilk Samples That Are rtPCR Positive
Measured: Delivery
Placental Samples That Are rtPCR Positive
Measured: Delivery
Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro
Measured: Delivery
Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro
Measured: Delivery
Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro
Measured: 6 weeks post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start4 Jan 2021
- Primary completion30 Apr 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corona Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 881 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703270
- Sponsor's protocol ID
- 2020.0276
- Acronym
- periCOVID
- Status last verified
- Aug 2024
- First submitted
- 7 Jan 2021
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding COVID-19 Infection in Pregnant Women and Their Babies
- ClinicalTrials.gov ID
- NCT04703270
- Acronym / sponsor ID
- periCOVID / 2020.0276
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 881 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 18 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women ≥ 24 weeks gestation in England.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
8 secondary outcomes
Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2
Time frame: At birth
Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery
Time frame: Delivery
Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery
Time frame: Delivery
Breastmilk Samples That Are rtPCR Positive
Time frame: Delivery
Placental Samples That Are rtPCR Positive
Time frame: Delivery
Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro
Time frame: Delivery
Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro
Time frame: Delivery
Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro
Time frame: 6 weeks post delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corona Virus Infection and Pregnancy Related, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Concentrations in Maternal Blood in Pregnant Women in England (time frame: Delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.