A global registry of women affected by COVID-19 in pregnancy and their babies, to guide treatment and prevention
| ISRCTN | ISRCTN68026880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68026880 |
| IRAS number | 282655 |
| Secondary identifying numbers | 20QC5917, IRAS 282655 |
- Submission date
- 29/04/2020
- Registration date
- 30/04/2020
- Last edited
- 28/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of April 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
There is a need to rapidly collect and pool data on pregnant women affected by suspected or confirmed COVID-19 to inform treatment and preventative strategies in this and future outbreaks. The aim of this study is to create a global registry gathering data on the effect of SARS-CoV-2 infection in pregnancy from healthcare systems around the world. The researchers are endorsed by the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) and the International Federation of Gynecology and Obstetrics (FIGO) who will support the study through their members and networks.
Who can participate?
Women aged 18-50 who are pregnant and their babies, with suspected or confirmed COVID-19
What does the study involve?
Data will be collected between January 2020 and March 2021 focusing on miscarriage, fetal growth restriction and stillbirth, pre-term delivery and potential transmission to the baby. The study will also collect data on ultrasound diagnosis and neonatal care not included in other more general studies. Data entry can be performed by any healthcare professional in maternity services. The researchers will engage with obstetricians (Attendings/Consultants and those in training) and midwives to ensure data collection is as wide and full as possible. Investigators can register their interest to add data to the registry through the web page (https://pan-covid.org). Once registered they will be asked to provide confirmation of their local approval, which will allow data entry.
What are the possible benefits and risks of participating?
There are no direct benefits or risks of participation, the data gathered will be used to inform treatment and prevention of COVID-19.
Where is the study run from?
Imperial College Healthcare NHS Trust (UK)
When is the study starting and how long is it expected to run for?
January 2020 to September 2021
Who is funding the study?
UK Research and Innovation
Who is the main contact?
Dr Edward Mullins
edward.mullins@imperial.ac.uk
Contact information
Public
Principal Investigator
Queen Charlotte's & Chelsea Hospital
Du Cane Road
London
London
W12 0HS
United Kingdom
 ORCID ID |
0000-0003-1886-6358 |
|---|---|
| Phone | +44 (0)20 3313 1111 |
| edward.mullins@imperial.ac.uk |
Study information
| Study design | Observational pregnancy register |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | https://pan-covid.org/Information-for-Participants.php |
| Scientific title | Pregnancy and Neonatal Outcomes in COVID-19: a global registry of women with suspected COVID-19 or confirmed SARS-CoV-2 infection in pregnancy and their neonates; understanding natural history to guide treatment and prevention |
| Study acronym | PAN-COVID |
| Study hypothesis | To understand the natural history of COVID-19 in pregnancy, in order to guide treatment and prevention during the outbreak. |
| Ethics approval(s) | Approved 09/04/2020, North West - Haydock Research Ethics Committee (3rd Floor - Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048387 or +44 (0)2071048165; haydock.rec@hra.nhs.uk), ref: 20/NW/0212 |
| Condition | COVID-19 (SARS-CoV-2 infection) in pregnancy and neonates |
| Intervention | The study will form a global disease registry linked with other national data sources for women with suspected COVID-19 or confirmed SARS-CoV-2 in pregnancy and their neonates. Investigators can register their interest to add data to the registry through the web page (https://pan-covid.org). Once registered they will be asked to provide confirmation of their local approval, which will allow data entry. Data will be collected from 01/01/2020 to 31/03/2021 on miscarriage, pre-term delivery, fetal growth restriction and neonatal outcomes, to assess the effect of a SARS-CoV-2 infection. |
| Intervention type | Other |
| Primary outcome measure | 1. Confirmed SARS-CoV-2 infection in women in pregnancy or their neonates, measured using routine clinical data from 01/01/2020 to 31/03/2021 2. Suspected SARS-CoV-2 (defined as woman self-isolating for suspected COVID-19 with symptoms, symptoms will be recorded) measured using routine clinical data from 01/01/2020 to 31/03/2021 |
| Secondary outcome measures | 1. Incidence of miscarriage measured using routine clinical data from 01/01/2020 to 31/3/2021 2. Incidence of fetal growth restriction and stillbirth measured using routine clinical data from 01/01/2020 to 31/3/2021 3. Incidence of preterm birth measured using routine clinical data from 01/01/2020 to 31/3/2021 4. Incidence of vertical transmission to the neonate measured using routine clinical data from 01/01/2020 to 31/3/2021 5. Co-morbidities measured using routine clinical data from 01/01/2020 to 31/3/2021 6. Medical history measured using routine clinical data from 01/01/2020 to 31/3/2021 7. Details of the delivery of baby/babies measured using routine clinical data from 01/01/2020 to 31/3/2021 |
| Overall study start date | 01/01/2020 |
| Overall study end date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | Approx. 1000 |
| Total final enrolment | 8239 |
| Participant inclusion criteria | 1. Women aged 18-50 who are pregnant and their babies 2. Suspected COVID-19 or confirmed SARs-CoV-2 infection 3. Delivery or pregnancy loss between January 2020 and March 2021 |
| Participant exclusion criteria | Individuals who do not meet the inclusion criteria |
| Recruitment start date | 01/01/2020 |
| Recruitment end date | 31/03/2021 |
Locations
Countries of recruitment
- Argentina
- Australia
- Austria
- Belgium
- Bosnia and Herzegovina
- Brazil
- Canada
- Chile
- Colombia
- Czech Republic
- Ecuador
- Egypt
- England
- Estonia
- Germany
- Greece
- Guatemala
- Hungary
- India
- Indonesia
- Ireland
- Israel
- Italy
- Japan
- Latvia
- Lebanon
- Malta
- Mexico
- Netherlands
- Nigeria
- Peru
- Portugal
- Qatar
- Romania
- Russian Federation
- South Africa
- Spain
- Thailand
- Tunisia
- Uganda
- United Arab Emirates
- United Kingdom
- United States of America
Study participating centre
London
W12 0HS
United Kingdom
Sponsor information
University/education
South Kensington
London
SW7 2BU
England
United Kingdom
| Phone | +44 (0)20 7589 5111 |
|---|---|
| y.borisova@imperial.ac.uk | |
| Website | http://www3.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The weekly reports of case data will be made available on the study website. In addition, results will be submitted to scientific journals, available as open-access, in Autumn 2021. |
| IPD sharing plan | CTR, Cardiff University is responsible for building, maintaining, cleaning and analysing the database. All enquiries should be directed to the PI, Edward Mullins (Edward.mullins@imperial.ac.uk) or Julia Townson (townson@cardiff.ac.uk). The data will be available upon request and an agreed/signed data-sharing agreement. De-identified participant data will be made available to the scientific community with as few restrictions as feasible, whilst retaining exclusive use until the publication of major outputs. Cardiff University holds data for 15 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 29/01/2021 | 01/02/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 19/07/2022 | 28/08/2024 | Yes | No |
Editorial Notes
28/08/2024: Publication reference and total final enrolment added.
01/02/2021: Publication reference added.
30/04/2020: Trial's existence confirmed by the NIHR.
