COVID-19 (SARS-CoV-2 infection) in pregnant women Infections and Infestations
Conditions
Interventions
This study is designed as a prospective cohort study of pregnant women admitted to hospital with suspected or confirmed COVID-19 infection who consent to participation in the study. Recruitment will b
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Pregnant women who are admitted to the hospital and have suspected (symptomatic) or confirmed COVID-19 infection and up to 2 weeks post-delivery 2. Age =18 years Note that women admitted for any reason, including non-COVID-19 related reasons such as obstetric reasons, will be included. Pregnant women may also be identified via the COVIDENCE-UK study (NCT04330599), a national observational cohort study of individuals enrolled from the community that can be potentially diagnosed with COVID-19.
Exclusion criteria
Exclusion criteria: 1. Patients unwilling to give consent 2. Unable to understand sufficient English, and no translator or translation services are available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function for mothers measured by spirometry at 3 months post-discharge (if COVID-19 infection coincides with delivery) or 3 months post-delivery (if COVID-19 infection does not result in or coincide with delivery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcome measures: 1. Lung function: Forced Expiratory Volume in one second (FEV1 measured in Litres); Forced Vital Capacity (FVC measured in Litres); Forced Expiratory Flow between 25% and 75% of vital capacity (FEF25-75 measured in Litres/sec) measured using NDD Easy on-PC spirometer and weight (for adjustment of lung function test) for mothers at 3, 6 and 12 months post-discharge, or post-delivery (in the event that admission for COVID-19 infection does not coincide with delivery) 2. A 6-minute walking test measuring how far in metres the participant can walk in 6 minutes, collected at 3, 6 and 12 months post-discharge or post-delivery 3. Breathlessness measured using a short MRC dyspnoea scale questionnaire, scored from 1 (best) to 5 (worst), collected at 3, 6 and 12 month follow up visits 4. Clinical information related to COVID-19 infection (symptoms, treatment and date of diagnosis) at baseline and delivery 5. Laboratory assessments (Protein to Creatinine Ratio in urine, Full blood count [FBC], Urea and Electrolytes [U&Es], LDH, Liver function tests [LFTs], D-Dimer, C-Reactive Protein [CRP]) at baseline, 3, 6 and 12 months post-discharge or post-delivery 6. Radiological findings on chest X-ray or CT chest (when clinically indicated) at baseline 7. Immunological profile measured using flow cytometry and qPCR at baseline, 3, 6 and 12 months post-discharge or post-delivery 8. Thromboembolic events collected from medical records during admission or within 6 weeks of delivery 9. Quality of life measured using EQ-5D-3L Questionnaire at 3, 6 and 12 months post-discharge or post-delivery At discharge (collected from medical records): 10. Length of hospital stay 11. Reason for admission 12. Admission to intensive care/high dependency unit | — |
Countries
England, United Kingdom
Contacts
Public ContactDoris Lanz
Outcome results
None listed