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

January 28, 2025 updated by: Irja Lutsar, University of Tartu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60739

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tartu, Estonia
        • University of Tartu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All the pregnant Estonian women who conceived and gave birth between February 27, 2020, and March 1, 2023

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women with COVID-19 and their offspring
Pregnant women who were diagnosed with COVID-19 during the study period, along with their offspring
Other: COVID-19 infection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19 incidence
Time Frame: From enrollment to March 2023
From enrollment to March 2023
Post-COVID condition incidence
Time Frame: From enrollment to March 2023
From enrollment to March 2023
Chronic diseases incidence
Time Frame: From enrollment to March 2023
From enrollment to March 2023
Newborn condition
Time Frame: From enrollment to March 2023
Apgar scores at birth
From enrollment to March 2023
Mortality
Time Frame: From enrollment to March 2023
From enrollment to March 2023
Hospitalization rate due to COVID-19
Time Frame: From enrollment to March 2023
From enrollment to March 2023
Pregnancy complications incidence
Time Frame: From enrollment to March 2023
From enrollment to March 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tartu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2020

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 382/M-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD collected throughout this trial will not be shared due to data protection laws.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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