The Combined First Trimester Screening

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorInstitute of Health Information and Statistics of the Czech Republic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Unsigned the Consent to Participate in the Project and the Consent to the Processing of Personal Data.

Trial population

Pregnant women matching all inclusion criteria \& GDPR.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group
Group A: A woman over 18 years old in the first trimester of pregnancy (11th-13th gestational week)

Trial outcomes

Primary outcomes

1

Proportion of women with identified increased risk of Preeclampsia, Fetal Growth Restriction or Fetal Chromosomal Aneuploidies (trisomies of chromosomes 21, 18 and 13)

Time frame
From June 2025 to October 2026

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Health Information and Statistics of the Czech Republic

Lead sponsor

University Hospital Olomouc

Collaborator

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

Collaborator

Krajská zdravotní, a.s. - Nemocnice Most, o.z.

Collaborator