Information for Women and their Families Thinking of Taking Part in the periCOVID Study  

If you have been diagnosed with COVID-19 in pregnancy you could help us get a better understanding of the how the disease affects pregnant women and their babies.

Do you meet the requirements for our study?

  • Over 18 years old

  • 24 weeks pregnant or more 

  • Live in England

  • Have been diagnosed with 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. We don't know yet if or how the infection might be transmitted to babies or how it may affect them if it is.

In order to improve our understanding we would like to take regular blood, urine and stool samples from pregnant women and their babies to test for coronavirus and immunity against 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. 

Taking part in the periCOVID trial  

When you are first diagnosed with COVID-19 the midwife or doctor looking after you will collect the following samples from you:

  • blood

  • throat swab

  • urine and rectal swabs

If you haven't delivered within a month the same samples will be taken again as part of your routine care in pregnancy. 

When your baby is born we would like to collect the following samples: 

  • From you: 

    • vaginal swab​

    • amniotic fluid swab

    • nasal swab

    • placental swab

    • colostrum swab

    • urine and rectal swabs

    • blood sample

  • From the baby: 

    • ​blood sample from the umbilical cord

    • nasal swab

    • urine and rectal swabs

.

When your baby is born 

Before your baby is born

When you and your baby go home 

In order to help us understand what happens after your baby is born we would like to the following from your baby;

  • nasal swab

  • urine swab

  • rectal swab

And from you;

  • throat swab

  • urine swab

  • rectal swab

For once a week until the baby is five weeks old. 

The doctor or midwife looking after you will help collect these samples while you and your baby are in hospital.

When you are discharged home, we will either give you the kits before discharge or post the kits to you and you will be able to take the samples yourself and post them back to us.

Your local doctor or midwife will remind you to take the weekly samples by phone, email and/or text.

In addition to these swab samples, we would also like to collect a breastmilk sample from you, and one blood sample from you and your baby at around 6 weeks after delivery.

 

Your local doctor or midwife will arrange this with you at a time and place that is convenient to you and your baby.

What happens to the samples and data you collect from me and my baby?

  • All your samples will be coded with an identification number that is unique to you and your baby and stored with all the other samples until they are tested.

  • They will be tested for the novel coronavirus and to see how your body fights against the coronavirus, including testing for antibodies against coronavirus. Finally, we will sequence the genome of the virus to better understand its biology.

  • All the samples will be destroyed after testing

  • You will have the opportunity to anonymously donate your and your baby’s samples to SGUL for future studies and/or to anonymously donate your blood samples to Public Health England where they will be used to further our research into the novel coronavirus.

  • If you do not want to donate your samples, this decision will not prevent you from taking part in the periCOVID study.

  • Should you wish, you have the opportunity to allow your and your baby’s anonymised data and/or results to be used for future studies. If you do not want them to be used for future studies, this decision will not prevent you from taking part in the periCOVID study"

  •  Your personal data will be stored in accordance with the General Data Protection Regulations (GDPR) and the Data Protection Act 2018.

What are the benefits to me?

  • We will tell you your and your baby’s results when all the testing is complete, which will likely be towards the end of the surveillance.

  • Taking part will also help provide important information to protect pregnant women, their babies and healthcare staff looking after them.

  • We will also produce a report of the overall results for the pregnant women in the surveillance for Public Health England and publish them in a medical journal

What are the disadvantages?

  • For some, blood sampling may cause momentary discomfort at the site of the blood draw, possible bruising, redness, and swelling around the site, bleeding at the site, feeling of light- headedness when the blood is drawn, and rarely, an infection at the site of the blood draw.

  • Whenever possible, we will aim to take some extra blood when you and your baby have your routine blood tests.

  • We do not anticipate any other disadvantages from taking part.

What if I change my mind?

  • If you no longer want to be involved, you can withdraw from the surveillance at any time by contacting us 

  • The samples you have already provided will continue to be processed but you and your baby will not be asked to provide any more samples.

How do we test for SARS-CoV-2 and COVID-19?

Throat Swabs

  • 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.

Blood Tests

  • 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

For more information on Covid-19
and pregnancy 

What should I do if I have any concerns?

If you have any concerns,

please talk to us.

If you are still unhappy, you can contact the

Complaints Manager,

Strategy Directorate,

Wellington House,

133-155 Waterloo Road,

London, SE1 8UG 

St George's University  of London

Cranmer Terrace,

Tooting,

London

SW17 0RE

United Kingdom

Sponsored by 

Public Health England,

Wellington House,

133 – 155 Waterloo Road,

London

SE1 8UG

© 2020 Public Health England and the periCOVID Research Group