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

Completed

• Conditions: Pregnancy; COVID-19; Post-COVID / Long-COVID; Newborn Health; Miscarriages

• Registration Number: NCT06806696
• Lead Sponsor: University of Tartu

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

Study Timeline

• Study Start: 2020-02-27
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60739

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID-19 incidence	From enrollment to March 2023
Post-COVID condition incidence	From enrollment to March 2023
Chronic diseases incidence	From enrollment to March 2023
Newborn condition	From enrollment to March 2023	Apgar scores at birth
Mortality	From enrollment to March 2023
Hospitalization rate due to COVID-19	From enrollment to March 2023
Pregnancy complications incidence	From enrollment to March 2023

Trial Locations

Locations (1)

University of Tartu; 🇪🇪 Tartu, Estonia