Combined first-trimester screening for pregnancy complications
Official title: The Combined First Trimester Screening
Run by Institute of Health Information and Statistics of the Czech Republic · NCT07015203 · Data updated 2026-11-12
This project tests a standardized first-trimester screening to see if it can identify pregnant women at 11–13 weeks who are at higher risk for preeclampsia, fetal growth restriction, chromosomal problems, and other serious complications.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 2000 (estimated) |
| Sponsor | Institute of Health Information and Statistics of the Czech Republic Government |
| Locations | 3 sites (Most, Czechia and 2 other locations) |
| Status | Recruiting |
| Started | June 15, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | April 30, 2027 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07015203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older in the first trimester of pregnancy (11th–13th gestational week) who sign informed consent and agree to personal data processing are eligible.
✕Probably not a fit
Women under 18, those outside the 11–13 week window, or those who decline consent or data-sharing are not eligible and would not receive benefit from this screening.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This national, prospective multicenter pilot will enroll about 2,000 pregnant women in the Czech Republic at 11–13 weeks of gestation. It collects maternal history, ultrasound measurements, biochemical and biophysical parameters and uses FMF‑certified software to calculate individual risks for preeclampsia, fetal growth restriction and common chromosomal aneuploidies. Collected clinical parameters will be linked with the Czech National Health Information System to enable unified recording, analysis and planning for reimbursement mechanisms. The project aims to standardize first‑trimester evaluation across participating centers and improve access to quality prenatal care.
Why it matters
Potential benefit: If successful, the program could identify high-risk pregnancies earlier and help ensure more consistent care and preventive treatment, potentially reducing severe obstetric complications.
How similar studies have gone: Similar FMF-based combined first-trimester screening approaches have been adopted internationally and have demonstrated improved detection of preeclampsia risk and chromosomal aneuploidies when properly implemented.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Unsigned the Consent to Participate in the Project and the Consent to the Processing of Personal Data.
Where it's running
-
Regional Health Corpotarion - Most Hospital
Most, Czechia, Czechia Recruiting -
University Hospital Olomouc
Olomouc, Czechia, Czechia Recruiting -
Institute for the Care of Mother and Child
Prague, Czechia, Czechia Recruiting
Study contacts
- Study coordinator: Petra Brlica Heideová, Msc.
- Email: Petra.BrlicaHeideova@uzis.cz
- Phone: +420 770 171 533
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.