COVID-19 infection in pregnancy (COVIpreg) [COVID-19]
Research type
Research Study
Full title
COVID-19 infection in pregnancy (COVIpreg); A prospective cohort study of immunological response and long-term maternal morbidity
IRAS ID
283699
Contact name
Stamatina Iliodromiti
Contact email
Sponsor organisation
Queen Mary University of London
ISRCTN Number
ISRCTN93266696
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Introduction & Aims:\n\nThe COVIpreg study is a prospective cohort study to assess the impact of COVID-19 infection on the long term outcomes in pregnant women. The main aim is to assess the impact of COVID-19 infection on long term outcomes in pregnant women including:\n\n•\tAssess the phenotypic risk factors, including ethnicity, that predispose pregnant women to severe COVID-19 infection.\n•\tPhenotype the immune response in the blood and the placenta of pregnant women admitted with COVID-19 infection.\n•\tCharacterise the short-term maternal morbidity and perinatal outcomes of pregnant women with COVID-19 infection.\n•\tAssess the medium to long-term pulmonary and extrapulmonary sequelae of pregnant women post COVID-19. \n\nThe primary outcome is maternal lung function at 3 months post discharge (for delivery), measured by spirometry. Secondary outcomes include longer term lung function, exercise capacity, obstetric and infant outcomes, and immunological profiles.\n\nStudy Population & Recruitment:\n\nThe study will be conducted across 3 London hospitals all within the Barts Health NHS Trust; we aim to recruit 200 patients over 6 months. \n \nAny pregnant women or women who have delivered within 2 weeks of being admitted to hospital with suspected or confirmed COVID-19 infection are eligible to participate. In addition, patients must be 16 years old or above, able to provide consent and understand sufficient English. All eligible women will be invited to participate in the study.\n\nData Collection:\n\nWe will collect routine and non-routine data at baseline, delivery, and at follow up visits 3, 6 and 12 months after discharge (for COVID-19 if the woman has not yet delivered).\n\nRoutine data will be collected from the medical records including: demographics (height, weight, ethnicity etc), medical and pregnancy history, COVID-19 infection status, maternal and routine laboratory outcomes. At delivery, we will also collect obstetric (pregnancy) and infant outcomes.\n\nAt follow up, we will collect maternal, perinatal and laboratory outcome data. \nNon-routine data will be collected in the form of: quality of life questionnaire, MRC dyspnoea questionnaire, 6 minute walk test, lung function test, urine test and immunology blood test (where a teaspoon of additional blood will be taken for research purposes). \n\nFor a subset of women who consent to this, we will collect cord blood and samples of the placenta for further immunological analysis.\n\nStudy Duration\n\nData will be collected up to 12 months after inclusion and the study duration will be for 24 months.
REC name
North West - Haydock Research Ethics Committee
REC reference
20/NW/0257
Date of REC Opinion
18 May 2020
REC opinion
Further Information Favourable Opinion