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OpenTrials
Completed

NCT Number: NCT06806696

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

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.

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Key information

Conditions

Pregnancy Abortion, Spontaneous COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Female Urogenital Diseases and Pregnancy Complications Infections Lung Diseases Miscarriages Newborn Health Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-COVID / Long-COVID Post-Infectious Disorders Pregnancy Complications RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Tartu

Tartu, Estonia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 infection

Other

COVID-19 diagnosis in the health database

Primary outcomes

  1. COVID-19 incidence

    Time frame: From enrollment to March 2023

  2. Post-COVID condition incidence

    Time frame: From enrollment to March 2023

  3. Chronic diseases incidence

    Time frame: From enrollment to March 2023

  4. Newborn condition

    Time frame: From enrollment to March 2023

    Apgar scores at birth

  5. Mortality

    Time frame: From enrollment to March 2023

  6. Hospitalization rate due to COVID-19

    Time frame: From enrollment to March 2023

  7. Pregnancy complications incidence

    Time frame: From enrollment to March 2023

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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