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

NCT06806696 | Completed

• 1 other identifier: 382/M-8
• Study Type: observational
• Target: 60,739
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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

  Apgar scores at birth

  From enrollment to March 2023

• 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

Study Arms (2)

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

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

Interventions

COVID-19 infection OTHER

COVID-19 diagnosis in the health database

Pregnant women with COVID-19 and their offspring

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• University of Tartu: lead

Study Sites (1)

University of Tartu

Tartu, Estonia

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Microbiology

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 4, 2025
• Study Start: February 27, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)