Clinical Trial

The Combined First Trimester Screening

Recruiting
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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 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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-06-03; most recent amendment 2026-04-16.
Status change: Not Yet Recruiting → Recruiting 2026-03-25
Trial Details
NCT Number NCT07015203
Lead Sponsor Institute of Health Information and Statistics of the Czech Republic
Collaborators: University Hospital Olomouc, Institute for the Care of Mother and Child, Prague, Czech Republic, Krajská zdravotní, a.s. - Nemocnice Most, o.z.
Conditions Preeclampsia (PE), Fetal Growth Restriction, Congenital Abnormalities, Preterm Labor, Intrauterine Fetal Demise, Genetics Syndrome, Pregnancy Overdue - Week 41+6
Enrollment 2,000 participants
Start Date 2025-06-15
Primary Completion 2026-10-31 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-17