How do I set up periCOVID up at my hospital?

• Identify who will lead for midwifery, obstetrics and neonatology 

• Email us to register your interest in the study 

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Do we need R&D and ethical approval to set up at my site?

• You don't need R&D approval to run periCOVID at your site

• periCOVID is a national surveillance study run by Public Health England(PHE) in partnership with St.George’s, University of London

• PHE has legal permission, provided by Regulation 3 of The Health Service (Control of Patient Information) Regulations 2002 to collect confidential patient information – for more information see study protocol

• Surveillance falls outside of the Health Research Authority remit for ethical review. This is in accordance with the revised guidance in the Governance Arrangements for Research Ethics Committees (GAfREC) that was released in September 2011. 

• This surveillance has been subject to an internal ethical review by the PHE Research Ethics and Governance Group, to ensure that it is fully compliant with all regulatory requirements. 

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Have you got any information that I can share with my colleagues before we start? 

• You can download a copy of our powerpoint presentation to share with colleagues here

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Other useful documents 

• Setting up a site file 

• Study flow chart   

• Standard operating procedure

• The periCOVID protocol

• A list of the sample collection equipment that we use

• Patient information leaflets

• Informed consent form

• How to collect the samples at delivery; information for clinical staff  

• How to collect the samples; information for patients

• How to mail the samples to St Georges; information for patients

• REDCap user manual for inputting clinical data into the study database

 

Are all available to download here:

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​What will you send me?​

• We will send you pre prepared packs for consenting patients, collecting and the mailing samples to our lab at St George’s 

• periCOVID stickers to identify patient notes

• All the other information that you need can be downloaded from this website 

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What is in the packs that you will send me?

• Box 1 (recruitment pack); maternal blood, throat, urine and rectal swabs

• Box 2 (one month follow up pack); maternal blood, throat, urine and rectal swabs

• Box 3 (delivery pack); maternal blood, throat, urine, rectal and breast milk (colostrum) swabs, high vaginal swab, placental swabs x2, amniotic fluid swab (if delivers by planned C-section) cord blood, infant nasal, urine and stool swabs

• Boxes 4-8 (weekly follow up packs); maternal throat, urine and rectal swabs, infant nasal, urine and stool swabs

• Box 9 (six week follow up pack); maternal blood, throat, urine, rectal and breast milk swabs, infant blood, nasal, urine, and stool swabs

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That is a lot of boxes where should we store them all?

• Box 1 to be allocated by Obstetrics team at recruitment

• Box 2 to be issued to the patient after COVID-19 diagnosis if she is more than 4 weeks before her delivery date

• Box 3 to be kept on Labour ward

• Boxes 4-9 to be issued to the patient on discharge from hospital after delivery 

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Where are the samples processed?

• All the samples will be processed in our lab at St. George’s

• Once they have been collected you seal them and place them in the prepaid box to return to us.

 

How do we get the samples to you?​

• Once you have collected and labeled the samples, place them in the clear plastic envelope provided, push out as much air as possible and seal the envelope

• Place the sealed envelope and specimen request form into the box and close it

• Place the box into the grey/white plastic envelope with UN3373 on the back and seal it

• This is pre addressed;   Suzy Lim

                                              Institute for Infection & Immunity

                                              Paediatric Infectious Diseases Research Group
                                              St George’s, University of London

                                              SW17 0RE

• The box will be sent through the DX system 

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What will I get out of this?​ 

• You can read a copy of our publication policy here

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I am ready to recruit a patient what next?

• Give the patient information about the study to read and keep

• If they are happy to participate ask them to sign two copies of the informed consent

• The patient should keep one copy of the consent form

• The original informed consent form should be stored locally by the recruiting team

• Open up the box 1 if your patient is an antenatal patient, box 3 if the patient is about to deliver

• Each pack has a unique patient identifying number for the mother and the baby or babies

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Do the patients all have to be recruited antenatally?

• No you can recruit any patient who is willing to take part in the study from 24/40 up until and including at delivery

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I have a patient who presented in labour who had a positive test after 24/40, but we didn’t take samples at that time, can they still be part of the study?

• Yes, if they have a documented positive result for SARS-CoV-2  at any point after 24/40 we would still like to take samples at delivery, you can consent them to be part of the study

 

My site is screening all the women booked for elective sections for SARS-CoV-2, if they test positive can I consent women who test  positive on the day of surgery?

• Yes, as long as they have not yet delivered, you can recruit these women to the study

 

I have a patient who presented in active labour and became unwell after delivery, she is two days post-natal and is COVID-19 positive, can I recruit her to the study?

• Sadly not

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I am ready to recruit at patient but the packs haven't arrived yet

• You can email us using your hospital email and we will issue a unique patient identifying number for your samples and give you access to the database 

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• You can download a copy of the patient information leaflet and two copies of the informed consent form here;

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• One signed copy of the informed consent should be stored locally and the other should be give to the patient 

• Samples can be taken using equipment detailed equipment list 

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• These should be stored in a secure place until the periCOVID team will provide you with a pre-labelled envelope allowing the samples to be sent to St George’s, University of London for processing

 

The patient only wants to consent to collecting the delivery and six-week postnatal samples – can they still be part of the study?

• Yes 

• Email us at PHE with the unique patient number to let us know

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The patient wants to withdraw from the study

• The patient can withdraw from the study at any time 

• Click on the link below 

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The patient that I consented delivered before 37/40 and the baby is now on the NICU, who should take the day 7 samples from the neonate?

• You should liaise with the neonatal unit to take these weekly until the baby is discharged

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