PregnancyNCT06806696
SARS-COV-2 VARIANTS' EFFECT ON PREGNANCY AND LONG-TERM OUTCOMES AMONG PREGNANT WOMEN AND THEIR NEWBORNS IN ESTONIA
An observational study of Pregnancy and COVID-19, run by University of Tartu at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pregnancy, COVID-19, Post-COVID / Long-COVID
- What is being tested?
- COVID-19 infection
- How many people
- 60,739 participants
- Where
- 1 siteEstonia
- Study dates
- 27 Feb 2020to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the pregnant Estonian women who conceived and gave birth between February 27, 2020, and March 1, 2023
Who may be able to join
- pregnancy (conceived and gave birth between February 27, 2020, and March 1, 2023) with COVID-19 or without and their newborns
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- COVID-19 infection
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 infectionOther
COVID-19 diagnosis in the health database
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with COVID-19 and their offspring | Pregnant women who were diagnosed with COVID-19 during the study period, along with their offspring Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 incidence
Measured: From enrollment to March 2023
Post-COVID condition incidence
Measured: From enrollment to March 2023
Chronic diseases incidence
Measured: From enrollment to March 2023
Newborn condition
Apgar scores at birth
Measured: From enrollment to March 2023
Mortality
Measured: From enrollment to March 2023
Hospitalization rate due to COVID-19
Measured: From enrollment to March 2023
Pregnancy complications incidence
Measured: From enrollment to March 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start27 Feb 2020
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60,739 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irja Lutsar, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806696
- Sponsor's protocol ID
- 382/M-8
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD collected throughout this trial will not be shared due to data protection laws.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-COV-2 VARIANTS' EFFECT ON PREGNANCY AND LONG-TERM OUTCOMES AMONG PREGNANT WOMEN AND THEIR NEWBORNS IN ESTONIA
- ClinicalTrials.gov ID
- NCT06806696
- Acronym / sponsor ID
- 382/M-8
- Conditions
- Pregnancy, COVID-19, Post-COVID / Long-COVID, Newborn Health, Miscarriages
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60,739 participants (actual)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with COVID-19 and their offspring | – | Other: COVID-19 infectionPregnant women who were diagnosed with COVID-19 during the study period, along with their offspring |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the pregnant Estonian women who conceived and gave birth between February 27, 2020, and March 1, 2023
Key inclusion criteria (1 listed)
- pregnancy (conceived and gave birth between February 27, 2020, and March 1, 2023) with COVID-19 or without and their newborns
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 infectionCOVID-19 diagnosis in the health database | Other | Pregnant women with COVID-19 and their offspring |
Primary outcome
COVID-19 incidence
Time frame: From enrollment to March 2023
Post-COVID condition incidence
Time frame: From enrollment to March 2023
Chronic diseases incidence
Time frame: From enrollment to March 2023
Newborn condition
Time frame: From enrollment to March 2023
Apgar scores at birth
Mortality
Time frame: From enrollment to March 2023
Hospitalization rate due to COVID-19
Time frame: From enrollment to March 2023
Pregnancy complications incidence
Time frame: From enrollment to March 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No. The IPD collected throughout this trial will not be shared due to data protection laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and COVID-19, run by University of Tartu at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 incidence (time frame: From enrollment to March 2023). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.