Clinical trial Recruiting at 3 sites Observational Ages 18 and up Women only

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 typeObservational
Ages18 Years and up
SexWomen only
Enrollment2000 (estimated)
SponsorInstitute of Health Information and Statistics of the Czech Republic
Government
Locations3 sites (Most, Czechia and 2 other locations)
StatusRecruiting
StartedJune 15, 2025
Main results expectedOctober 31, 2026
Study endsApril 30, 2027
Registry record updatedApril 17, 2026
Trial IDNCT07015203 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.