Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Control Intervention1: COVID negative women: COVID negative women matched for month of admission
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Exposed Group: Inclusion criteria: For women • Pregnant, post abortal or post-natal women of all ages admitted to hospital. • Admitted in antenatal period/ labour/ postpartum period. • Positive lab test(s) (described below at “Definition of Exposure Status ?) for SARS-CoV-2 infection using throat or nasal swab specimens from the upper respiratory tract using ICMR’s standard testing protocol. • Willing to participate in the study. For Neonates • Neonates (up to 28 days) who are born to womenpositive for SARS-CoV-2 infection and whose parents/ LAR give consent. OR • Born to SARS-CoV-2 negative women (Retrospective data collection from the time while testing for SARS-CoV-2 was mandatory by Govt Rules). Unexposed Group Inclusion criteria • -Pregnant women of all ages admitted to the hospital when COVID testing was mandatory in hospitals. • Women who had any pregnancy outcomes during the hospital stay (live birth, still birth, abortion, ectopic pregnancy termination) • Negative lab test for SARS-CoV-2 infection using throat or nasal swab specimens from the upper respiratory tract using ICMR’s standard testing protocol. • No history of past infection with SARS-CoV-2 during the current pregnancy • Willing to participate in the study Definition of Exposure status 1. Exposed status will consist of pregnant women who have had positive testing by RT-PCR, TrueNat, CBNAAT, Molecular Test, Serological Antibody Test, and Rapid Antigen Test for SARS-CoV-2 during their current pregnancy or postpartum period either at the time of admission or during hospital stay. 2. Unexposed status will consist of pregnant women who have had negative testing for SARS-CoV-2 IgG/IgM at time of study entry and at endpoints: end of pregnancy. (RT-PCR, TrueNat, CBNAAT, Molecular Test, Serological Antibody Test, Rapid Antigen Test testing) or demonstrate seroconversion after enrollment, they will cross-over to the exposed group.
Exclusion criteria
Exclusion criteria: Not willing to provide consent (for prospective data collection)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Among SARS-COV-2 positive women only: Spectrum of COVID-19 symptoms during pregnancy Outcome of pregnancy in relation to severity of COVID-19symptoms Treatment pattern in relation to pregnancy and disease outcomes Neonatal SARS CoV-2 positivity rate Neonatal clinical features and outcomes in case of SARS-CoV-2 positivity Among both SARS-COV-2 positive and negative women- Perinatal complications and outcomes Outcome of pregnancy Neonatal clinical features and outcomes Timepoint: At enrollment At delivery 28 days 42 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Neonatal deaths Postpartum morbidity Maternal deathsTimepoint: 28 days 42 days 42 days | — |
Countries
India
Contacts
Public ContactDr Amlin Shukla
Indian Council of Medical Research
Outcome results
None listed