The Combined First Trimester Screening

NCT07015203 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

  • Preeclampsia (PE)
  • Fetal Growth Restriction
  • Congenital Abnormalities
  • Preterm Labor
  • Intrauterine Fetal Demise
  • Genetics Syndrome
  • Pregnancy Overdue - Week 41+6

Sponsors & Collaborators

  • University Hospital Olomouc

    collaborator OTHER
  • Institute for the Care of Mother and Child, Prague, Czech Republic

    collaborator OTHER
  • Krajská zdravotní, a.s. - Nemocnice Most, o.z.

    collaborator OTHER
  • Institute of Health Information and Statistics of the Czech Republic

    lead OTHER_GOV

Principal Investigators

  • Marek Ľubušký, prof. · THE FETAL MEDICINE CENTRE, Department of Obstetrics and Gynecology, Palacky University Olomouc, Faculty of Medicine and Dentistry, University Hospital Olomouc

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2026-10-31
Completion
2027-04-30

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015203 on ClinicalTrials.gov