The Combined First Trimester Screening

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-15

Study Completion Date

2027-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Non-invasive Placental Chromosome Exploration of Intrauterine Growth Restriction

NCT05023161

Fetal Growth Retardation

RECRUITING

First Trimester Risk Assessment Based on Ultrasound and Cell-free DNA vs Combined Screening

NCT04077060

Aneuploidy

COMPLETED NA

Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

NCT03067298

Preeclampsia Preterm Birth Fetal Growth Restriction +1 more

COMPLETED

Urinary Tract Dilations in Prenatal and Postnatal Life

NCT06317623

Urinary Tract Dilatation

RECRUITING

Prediction of Preeclampsia by Comprehensive Markers.

NCT03665623

Pre-Eclampsia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marek Ľubušký, prof.

Role: STUDY_DIRECTOR

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