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The Combined First Trimester Screening

The Combined First Trimester Screening

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07015203
Enrollment
2000
Registered
2025-06-11
Start date
2025-06-15
Completion date
2027-04-30
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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 global goal of the project is to develop and implement an appropriate care system for pregnant women, specifically by unifying (standardizing) the process of assessing the fetal anomaly scan and the risk of preeclampsia. This examination in first trimester of pregnancy is not routinely covered by public health insurance and is therefore not available to all women. By standardizing and unifying the screening process, the quality and accessibility of care will be improved for all population groups. This will lead to better health outcomes for the population, including socially excluded groups. The methodology will be tested on a sample of 2000 women in the first trimester of pregnancy. The combined firts trimester screening will include collecting the required parameters maternal, ultrasound, biochemical and biophysical. The Fetal Medicine Foundation (FMF) certified software will be used to determine them. FMF certified software will be used to calculate/assess the individual risk of developing pre-eclampsia, fetal growth restriction and the occurrence of fetal chromosomal aneuploidies (trisomies of chromosomes 21, 18 and 13) based on the input parameters. The project is supported by the European Social Fund Plus (Operational Program Employment plus) and the state budget of the Czech Republic and is registered by the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22\_005/0003855.

Interventions

None listed

Sponsors

Institute of Health Information and Statistics of the Czech Republic
Lead SponsorOTHER_GOV
University Hospital Olomouc
CollaboratorOTHER
Institute for the Care of Mother and Child, Prague, Czech Republic
CollaboratorOTHER
Krajská zdravotní, a.s. - Nemocnice Most, o.z.
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Czechia

Contacts

CONTACTPetra Brlica Heideová, Msc.
Petra.BrlicaHeideova@uzis.cz+420 770 171 533
CONTACTLucie Mandelová, PhD
lucie.mandelova@uzis.cz+420 770 190 828
STUDY_DIRECTORMarek Ľubušký, prof.

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026