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NCT Number: NCT07015203

The Combined First Trimester Screening

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lucie Mandelová, PhD

CONTACT

[email protected]

+420 770 190 828

Petra Brlica Heideová, Msc.

CONTACT

[email protected]

+420 770 171 533

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • Institute for the Care of Mother and Child, Prague, Czech Republic
  • Krajská zdravotní, a.s. - Nemocnice Most, o.z.
  • University Hospital Olomouc

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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