Information for Women and their Families Thinking of Taking Part in the periCOVID Study
If you have been diagnosed with COVID-19 in pregnancy or vaccinated against the disease you could help us get a better understanding of the how the disease affects pregnant women and their babies.
If you are;
Over 18 years old
24 weeks pregnant or more
Live in England
Have EVER been diagnosed with COVID-19
or vaccinated against COVID-19
If you answered yes to the above, then you are eligible to take part on in our study
The novel coronavirus outbreak is spreading rapidly and we know very little about the risk of infection in pregnant women and if or how the infection might be transmitted to babies or how it may affect them.
We are also interested in understanding what protection is passed from mothers who have been vaccinated to their babies through the umbilical cord and in breastmilk. In order to understand this, we would like to take regular samples from pregnant women and their babies, or from women who are breastfeeding and have received a SARS-CoV-02 vaccine to test for the novel coronavirus and immunity against the novel coronavirus.
We also want to understand how you might pass protective antibodies via the placenta and in breastmilk to your baby and if this protects your baby from the coronavirus.
If you are interested in taking part please take your time to read through the information below.
If you have any questions you can contact our team for more information.
You can download a copy of the patient information leaflet here.
How can you help?
If you decide to take part, you will be asked to sign a consent form. If you are unable to sign then you would not be able to participate in this study.
The doctor or midwife looking after you or the research team at your hospital will complete an online questionnaire about your health and, after your baby is born, the health of your baby.
This questionnaire will use an identification number and will not have your name or any other personal information about you.
We will arrange all the tests for you with the doctors and midwives who are looking after you or the research team. For women who are enrolled directly into the surveillance by SGUL, we will provide you with all of the equipment required for the collection of samples and to safely return them to the laboratory. It is at your doctor or midwife’s discretion whether the samples are taken, however they will remain your property until they are sent to SGUL.
If you decide to take part, we will use the results from the nasal and/or throat swab which has already been done during your pregnancy if you have had one. We may ask to take a blood sample from you when you join the study if you have received a COVID-19 vaccine during your pregnancy or if you received it after delivery and are breastfeeding.
What happens to the samples and data you collect from me and my baby?
Your samples will be coded with an identification number that is unique to you and your baby. The identification number will be stored with all the other samples until they are tested.
We will test your samples for coronavirus infection, to see if your immune system has made antibodies against the virus. Finally, we will sequence the genome of the virus to better understand its biology.
The samples will all be destroyed after testing.
However, should you wish, you have the opportunity to anonymously donate your and your baby’s samples to SGUL for storage in our Institute of Infection and Immunity Research Tissue bank, to help with future research. If you do not want to donate your samples, this decision will not prevent you from taking part in the periCOVID study. Any samples that are stored long-term at SGUL will not contain any personal data (such as name and address) of you or your baby, and the study code will be removed so it will not be possible for researchers to identify you or your baby.
Your personal data will be stored in accordance with the General Data Protection Regulations (GDPR) and the Data Protection Act 2018.
How do we test for SARS-CoV-2 and COVID-19?
Current UK guidelines recommend that COVID-19 is diagnosed by taking a swab from the nose or back of the throat.
If this is taken in the first 7 days of the infection it can be tested for genetic material from the virus.
A positive result from a throat swab tells you if you are currently (are) infected.
These can be used to test if you are currently infected with the virus.
Or if your immune system produced antibodies against the virus when you were infected.
I am interested in taking part what do I do next?
You can download a copy of our patient information form here:
If you would like more information you can contact our team here:
Complaints or concerns
If you have any concerns or complaints please contact PALS or the research team at the hospital that you were recruited at.
Or the periCOVID team: