The Combined First Trimester Screening

NCT07015203 | Recruiting

• 1 other identifier: UZIS 2025/4
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 3

Brief 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

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

Keywords

preeclampsia; prediction; prevention; maternal risk factors; Mean Arterial Pressure; Uterine artery Pulsatility Index; Placental Growth Factor; acetylsalicylic acid; Czech Republic

Outcome Measures

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)

  From June 2025 to October 2026

Study Arms (1)

A woman over 18 years old in the first trimester of pregnancy (11th-13th gestational week)

A participant in the project must have signed the Consent to Participate in the Project and the Consent to the Processing of Personal Data.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women matching all inclusion criteria \& GDPR.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Health Information and Statistics of the Czech Republic: lead
• 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

Study Sites (3)

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

MeSH Terms

Conditions

Pre-Eclampsia; Fetal Growth Retardation; Congenital Abnormalities; Obstetric Labor, Premature; Stillbirth; Genetic Diseases, Inborn

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor Complications; Fetal Death; Death

Study Officials

• Marek Ľubušký, prof.

  THE FETAL MEDICINE CENTRE, Department of Obstetrics and Gynecology, Palacky University Olomouc, Faculty of Medicine and Dentistry, University Hospital Olomouc

  STUDY DIRECTOR

Central Study Contacts

Petra Brlica Heideová, Msc.

CONTACT

+420 770 171 533; Petra.BrlicaHeideova@uzis.cz

Lucie Mandelová, PhD

CONTACT

+420 770 190 828; lucie.mandelova@uzis.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)