Combined first-trimester screening for pregnancy complications
The Combined First Trimester Screening
Institute of Health Information and Statistics of the Czech Republic · NCT07015203
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institute of Health Information and Statistics of the Czech Republic (other gov) |
| Locations | 3 sites (Most, Czechia and 2 other locations) |
| Trial ID | NCT07015203 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Most, Czechia and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preeclampsia, Fetal Growth Restriction, Congenital Abnormalities, Preterm Labor, Intrauterine Fetal Demise, Genetics Syndrome, Pregnancy Overdue - Week 41+6, preeclampsia