Preeclampsia (PE)NCT07015203
The Combined First Trimester Screening
An observational study of Preeclampsia (PE) and Fetal Growth Restriction, run by Institute of Health Information and Statistics of the Czech Republic at 3 sites in Czechia.
Trial summary
The project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic. The combined first trimester screening is aimed at predicting and detecting the most serious obstetric complications, such as the great obstetrical… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia (PE), Fetal Growth Restriction, Congenital Abnormalities
- How many people
- 2,000 participants
- Where
- 3 sitesCzechia
- Study dates
- 15 Jun 2025to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women matching all inclusion criteria \& GDPR.
Who may be able to join
- A woman over 18 years old in the first trimester of pregnancy (11th-13th gestational week)
- Signed the Consent to Participate in the Project and GDPR.
Who cannot join
- Unsigned the Consent to Participate in the Project and the Consent to the Processing of Personal Data.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia3 sites, 3 recruiting
- Recruiting
Regional Health Corpotarion - Most Hospital
Most, Czechia
Marian Kacerovský, Prof., +420777657991, KacerovskyM@lfhk.cuni.cz
Marian Kacerovský, Prof.
- Recruiting
University Hospital Olomouc
Olomouc, Czechia
Michaela Maděrková Tozzi, MD., Ph.D., +420724991367, cfm@fnol.cz
Michaela Maděrková Tozzi, MD., Ph.D.
- Recruiting
Institute for the Care of Mother and Child
Prague, Czechia
Ladislav Krofta, Prof., +420296511837, ladislav.krofta@upmd.eu
Ladislav Krofta, Prof.
About this study
The project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic.
The combined first trimester screening is aimed at predicting and detecting the most serious obstetric complications, such as the great obstetrical syndromes (preeclampsia, fetal growth restriction, preterm labor and intrauterine fetal demise "IUFD") and structural congenital defects (morphological and chromosomal).
The primary objective of the project is to create a unified methodology for performing and evaluating the combined first trimester screening in connection with the National Health Information System (hereinafter referred to as "NHIS"), which will enable recording, providing analysis and linking recorded clinical parameters with data in the NHIS. The pilot project will also provide data for modeling appropriate mechanisms for reimbursement from public health insurance.
Read the detailed description
The project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic.
The global goal of the project is to develop and implement an appropriate care system for pregnant women, specifically by unifying (standardizing) the process of assessing the fetal anomaly scan and the risk of preeclampsia. This examination in first trimester of pregnancy is not routinely covered by public health insurance and is therefore not available to all women. By standardizing and unifying the screening process, the quality and accessibility of care will be improved for all population groups. This will lead to better health outcomes for the population, including socially excluded groups.
The methodology will be tested on a sample of 2000 women in the first trimester of pregnancy.
The combined firts trimester screening will include collecting the required parameters maternal, ultrasound, biochemical and biophysical. The Fetal Medicine Foundation (FMF) certified software will be used to determine them. FMF certified software will be used to calculate/assess the individual risk of developing pre-eclampsia, fetal growth restriction and the occurrence of fetal chromosomal aneuploidies (trisomies of chromosomes 21, 18 and 13) based on the input parameters.
The project is supported by the European Social Fund Plus (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0003855.
- Conditions
- Preeclampsia (PE), Fetal Growth Restriction, Congenital Abnormalities, Preterm Labor, Intrauterine Fetal Demise, Genetics Syndrome
- Keywords
- preeclampsia, prediction, prevention, maternal risk factors, Mean Arterial Pressure, Uterine artery Pulsatility Index, Placental Growth Factor, acetylsalicylic acid, Czech Republic
- Medical subject headings
- Pre-Eclampsia, Fetal Growth Retardation, Congenital Abnormalities, Obstetric Labor, Premature, Stillbirth, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A woman over 18 years old in the first trimester of pregnancy (11th-13th gestational week) | A participant in the project must have signed the Consent to Participate in the Project and the Consent to the Processing of Personal Data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women with identified increased risk of Preeclampsia, Fetal Growth Restriction or Fetal Chromosomal Aneuploidies (trisomies of chromosomes 21, 18 and 13)
Measured: From June 2025 to October 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Jun 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- University Hospital Olomouc, Institute for the Care of Mother and Child, Prague, Czech Republic, Krajská zdravotní, a.s. - Nemocnice Most, o.z.
- Responsible party
- Sponsor
- Investigators
- Marek Ľubušký, prof., Study director, THE FETAL MEDICINE CENTRE, Department of Obstetrics and Gynecology, Palacky University Olomouc, Faculty of Medicine and Dentistry, University Hospital Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015203
- Sponsor's protocol ID
- UZIS 2025/4
- Status last verified
- Apr 2026
- First submitted
- 3 Jun 2025
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined First Trimester Screening
- ClinicalTrials.gov ID
- NCT07015203
- Acronym / sponsor ID
- UZIS 2025/4
- Conditions
- Preeclampsia (PE), Fetal Growth Restriction, Congenital Abnormalities, Preterm Labor, Intrauterine Fetal Demise, Genetics Syndrome
- Keywords
- preeclampsia, prediction, prevention, maternal risk factors, Mean Arterial Pressure, Uterine artery Pulsatility Index, Placental Growth Factor, acetylsalicylic acid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- University Hospital Olomouc, Institute for the Care of Mother and Child, Prague, Czech Republic, Krajská zdravotní, a.s. - Nemocnice Most, o.z.
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Jun 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 project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic.
The combined first trimester screening is aimed at predicting and detecting the most serious obstetric complications, such as the great obstetrical syndromes (preeclampsia, fetal growth restriction, preterm labor and intrauterine fetal demise "IUFD") and structural congenital defects (morphological and chromosomal).
The primary objective of the project is to create a unified methodology for performing and evaluating the combined first trimester screening in connection with the National Health Information System (hereinafter referred to as "NHIS"), which will enable recording, providing analysis and linking recorded clinical parameters with data in the NHIS. The pilot project will also provide data for modeling appropriate mechanisms for reimbursement from public health insurance.
Detailed description
The project is a national, prospective, multicenter pilot project. The project is focus on setting up the combined first trimester screening in the Czech Republic.
The global goal of the project is to develop and implement an appropriate care system for pregnant women, specifically by unifying (standardizing) the process of assessing the fetal anomaly scan and the risk of preeclampsia. This examination in first trimester of pregnancy is not routinely covered by public health insurance and is therefore not available to all women. By standardizing and unifying the screening process, the quality and accessibility of care will be improved for all population groups. This will lead to better health outcomes for the population, including socially excluded groups.
The methodology will be tested on a sample of 2000 women in the first trimester of pregnancy.
The combined firts trimester screening will include collecting the required parameters maternal, ultrasound, biochemical and biophysical. The Fetal Medicine Foundation (FMF) certified software will be used to determine them. FMF certified software will be used to calculate/assess the individual risk of developing pre-eclampsia, fetal growth restriction and the occurrence of fetal chromosomal aneuploidies (trisomies of chromosomes 21, 18 and 13) based on the input parameters.
The project is supported by the European Social Fund Plus (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0003855.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A woman over 18 years old in the first trimester of pregnancy (11th-13th gestational week) | – | –A participant in the project must have signed the Consent to Participate in the Project and the Consent to the Processing of Personal Data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women matching all inclusion criteria \& GDPR.
Key inclusion criteria (2 listed)
- A woman over 18 years old in the first trimester of pregnancy (11th-13th gestational week)
- Signed the Consent to Participate in the Project and GDPR.
Key exclusion criteria (1 listed)
- Unsigned the Consent to Participate in the Project and the Consent to the Processing of Personal Data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of women with identified increased risk of Preeclampsia, Fetal Growth Restriction or Fetal Chromosomal Aneuploidies (trisomies of chromosomes 21, 18 and 13)
Time frame: From June 2025 to October 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Marek Ľubušký, prof. study director
THE FETAL MEDICINE CENTRE, Department of Obstetrics and Gynecology, Palacky University Olomouc, Faculty of Medicine and Dentistry, University Hospital Olomouc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia (PE) and Fetal Growth Restriction, run by Institute of Health Information and Statistics of the Czech Republic at 3 sites in Czechia.
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 2 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Brlica Heideová, Msc. (+420 770 171 533, Petra.BrlicaHeideova@uzis.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women with identified increased risk of Preeclampsia, Fetal Growth Restriction or Fetal Chromosomal Aneuploidies (trisomies of chromosomes 21, 18 and 13) (time frame: From June 2025 to October 2026). 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 17 Apr 2026.