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The Combined First Trimester Screening to Predict Pregnancy Complications in Czech Republic
Led by Institute of Health Information and Statistics of the Czech Republic · Updated on 2026-04-17
2000
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
Sponsors
I
Institute of Health Information and Statistics of the Czech Republic
Lead Sponsor
U
University Hospital Olomouc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a national, prospective, multicenter pilot project in the Czech Republic to establish a standardized combined first trimester screening for pregnant women. This screening aims to predict and detect serious obstetric complications such as preeclampsia, fetal growth restriction, preterm labor, intrauterine fetal demise, and structural congenital defects, including chromosomal abnormalities. The study seeks to create a unified method for performing and evaluating this screening linked with the National Health Information System to improve care quality and accessibility. The screening process includes collecting maternal, ultrasound, biochemical, and biophysical parameters during the first trimester of pregnancy (11th-13th week). Certified software from the Fetal Medicine Foundation will be used to assess individual risks for preeclampsia, fetal growth restriction, and fetal chromosomal aneuploidies like trisomies 21, 18, and 13. The project plans to test this methodology on a sample of 2000 women and aims to support the development of reimbursement mechanisms from public health insurance. Participants will be involved during the first trimester, providing data for analysis and risk assessment. The study will measure the proportion of women identified with increased risk for the targeted conditions from June 2025 to October 2026. Women must consent to participate and allow processing of personal data. This observational study is supported by national and European funds and strives to enhance pregnancy care outcomes for all population groups, including socially excluded communities.
CONDITIONS
Brief Title
The Combined First Trimester Screening
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Consent to the Processing of Personal Data
You will not qualify if you...
- Not having signed the Consent to Participate in the Project and the Consent to the Processing of Personal Data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At 11th to 13th gestational week
Participants undergo combined first trimester screening including maternal, ultrasound, biochemical, and biophysical assessments to evaluate risks for pregnancy complications.
1 visit (in-person)
Duration - Until delivery
Participants are observed for pregnancy outcomes based on the screening results.
Trial Site Locations
Total: 3 locations
1
Regional Health Corpotarion - Most Hospital
Most, Czechia, Czechia
Actively Recruiting
2
University Hospital Olomouc
Olomouc, Czechia, Czechia
Actively Recruiting
3
Institute for the Care of Mother and Child
Prague, Czechia, Czechia
Actively Recruiting
Research Team
P
Petra Brlica Heideová, Msc.
L
Lucie Mandelová, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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