Last Updated

16 Sep 2020

Pregnancy and Neonatal Outcomes in COVID-19

Objectives

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.

Principal Institution(s)

Principal Investigator
Rationale and Abstract

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.

Study Design

Observational; Retrospective

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.

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
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