About periCOVID 

This surveillance has been set up as part of Public Health England’s (PHE) response to the national outbreak of the novel coronavirus. It aims to answer important questions about the impact of the novel coronavirus on pregnant women and their infants, and the mode of transmission from mother to baby.

By collecting sequential samples from pregnant women with confirmed coronavirus disease and, after childbirth, from the newborn infant, we hope to better understand the risk and mode of perinatal transmission of the novel coronavirus in order to develop an evidence base for recommendations, guidance and policy decisions for the clinical and public health management of pregnant women, their infants and the healthcare staff that care for them.

Primary Objective

  • To assess the risk of COVID-19 infection in newborn infants born to pregnant women with confirmed COVID-19 infection and determine possible routes of mother-to-child transmission

 

Secondary Objectives

  • To genetically sequence SARS-CoV-2 samples

  • To test for SARS-CoV-2 in the pregnant woman

  • To test for SARS-CoV-2 in the placenta and cord blood at birth

  • To test for SARS-CoV-2 in newborn infants of women with confirmed COVID-19

  • To assess the immune responses to SARS-CoV-2 in pregnant women and their babies

  • To determine whether SARS-CoV-2 is found in breast milk

  • To determine whether SARS-CoV-2 is found in neonatal urine and faeces

  • To determine the duration of excretion of SARS-CoV-2 in all mother and baby samples

Who are we recruiting?

  • Any pregnant woman with confirmed COVID-19 infection from 24 weeks gestation (i.e. viable foetus) in England

  • Potential participants will be provided with an information leaflet and asked to sign a consent form (or next of kin, if participant unable to give consent)

  • Pregnant women (including those who present during labour) will have as long as they require to consider taking part in the surveillance.

  • Exclusion criteria: if the mother is under 18 or is unable to give informed consent

Data collection;

Following informed consent, each participant will be allocated a unique 4-digit number. The consenting clinician then fills out a  brief proforma in order to capture the following information :

  • Maternal characteristics (age, ethnicity, significant past medical history)

  • Onset and duration of symptoms

  • Method of SARS-CoV-2 confirmation (PCR results, swab type, commercial platform)

  • Pregnancy information (gestational age at diagnosis, number of foetuses, pregnancy related complications, radiology findings, laboratory findings, ventilation support, ICU admission, estimated foetal weight, foetal abnormalities)

  • Delivery information (Gestational age at delivery, delivery method, intrapartum complications, postpartum complications, placental pathology)

  • Neonatal outcomes (Evidence of COVID-19, NICU admission, respiratory morbidity, duration and type of ventilation support, infectious morbidity, neurological morbidity)

  • Breastfeeding outcomes during the postnatal surveillance period

What samples are we collecting?

At recruitment to the study - the periCOVID team provide kits for clinicians to use to collect samples. We will work with the recruiting obstetric teams to obtain timely samples from the mother following her diagnosis of COVID-19 in the most pragmatic way, the following samples should be collected;

  • throat swab 

  • rectal swab

  • urine swab

  • blood 

We will aim to collect the same samples from the woman if she hasn't delivered 4-6 weeks later.

 

At delivery; from the mother 

 We will collect the same samples; throat swab, faces, urine and blood as well as;

  • maternal high vaginal swab

  • amniotic fluid swab

  • placental swab

  • cord blood 

  • and breastmilk/colostrum

From the neonate within 48 hours of delivery 

  • nasal swab

  • urine swab

  • rectal swab

  • blood sample only if cord blood is not available 

Weekly samples until 6 weeks 

Weekly samples will be taken with the help of the obstetric and neonatal teams whilst the mother and the baby are in the hospital. If they are discharged from hospital, we will either give the sampling kits to the woman before discharge or post the sampling kits to their residence with clear instructions on how to take the different samples (except blood) themselves.

 

The doctors or midwives will remind the women of their appointments and to take the weekly samples by phone, email and/or text. We will work with the obstetric and neonatal teams on collecting the blood sample from the mother and baby at 6 weeks, either at their residence or at the hospital. The blood sample will be taken by an experienced member of staff.

 

 

Data entry, analysis and presentation

Data collection will be co-ordinated between PHE Colindale and SGUL, where all the data will be held and all data analysis performed. A secure electronic database will be developed for this purpose and sites will be asked to complete questionnaires directly online.

We will perform interim analysis after the results of the first 100 participants become available. We will produce an interim report for the PHE COVID response team

Publication. 

The final results will be reported to relevant authorities. A paper containing the overall results may be submitted for publication in a peer-reviewed journal. 

 

The periCOVID publication policy is based on the Committee On Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE). 

 

 

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