SARS-COV-2 VARIANTS' EFFECT ON PREGNANCY AND LONG-TERM OUTCOMES AMONG PREGNANT WOMEN AND THEIR NEWBORNS IN ESTONIA

NCT ID: NCT06806696

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60739 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-27
• Study Completion Date: 2023-03-01

Brief Summary

The main aim of the study is to describe the possible impacts of SARS-CoV-2 and its various genotypes on pregnancy and long-term outcomes among pregnant women and their newborns in Estonia.

Detailed Description

All the pregnant women in Estonia who conceived and gave birth between February 27, 2020, and March 1, 2023 were included in the study. Pregnant women will be divided into 2 groups: 1. pregnant women who were diagnosed with COVID-19 during the study period, along with their newborns; 2. control group: pregnant women who did not have COVID-19 during pregnancy, along with their newborns. The following data is collected for each subject: prior vaccination, previous COVID-19 infection, underlying diseases/conditions, hospitalization, need for intensive care, need for mechanical ventilation and/or oxygen therapy, death cases, post-COVID-19 symptoms, pregnancy course and outcomes, possible virus transmission from mother to child, and the newborn's condition or accompanying health issues

Conditions

Pregnancy; COVID-19; Post-COVID / Long-COVID; Newborn Health; Miscarriages

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Pregnant women with COVID-19 and their offspring

Pregnant women who were diagnosed with COVID-19 during the study period, along with their offspring

COVID-19 infection

Intervention Type: OTHER

COVID-19 diagnosis in the health database

Pregnant women who did not have COVID-19 and their offspring

Pregnant women who did not have COVID-19 during pregnancy, along with their offspring

No interventions assigned to this group

Interventions

COVID-19 infection

COVID-19 diagnosis in the health database

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• pregnancy (conceived and gave birth between February 27, 2020, and March 1, 2023) with COVID-19 or without and their newborns

Exclusion Criteria

• NA

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tartu

OTHER

Sponsor Role: lead

Responsible Party

Irja Lutsar

Professor of Medical Microbiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Tartu

Tartu, , Estonia

Countries

Estonia

Other Identifiers

382/M-8

Identifier Type: -

Identifier Source: org_study_id