ational Registry for COVID in Pregnant wome

Not Applicable

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/12/030164
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Exposed Group:

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

Not willing to provide consent (for prospective data collection)

Study & Design

• Study Type: Observational
• Study Design: Not specified