CTRI/2020/12/030164招募中未知
ational Registry on SARS-COV-2- infection among pregnant women and their neonates (PanInPregCOVID Registry) - NRCIP
试验速览
- 阶段
- 未知
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Exposed Group:
- •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.
排除标准
- •Not willing to provide consent (for prospective data collection)
研究者
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