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Recruiting NCT07015203

NCT07015203 The Combined First Trimester Screening

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Clinical Trial Summary
NCT ID NCT07015203
Status Recruiting
Phase
Sponsor Institute of Health Information and Statistics of the Czech Republic
Condition Preeclampsia (PE)
Study Type OBSERVATIONAL
Enrollment 2,000 participants
Start Date 2025-06-15
Primary Completion 2026-10-31

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 2,000 participants in total. It began in 2025-06-15 with a primary completion date of 2026-10-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Petra Brlica Heideová, Msc.

✉ Petra.BrlicaHeideova@uzis.cz

📞 +420 770 171 533

Principal Investigator

Marek Ľubušký, prof.

STUDY DIRECTOR

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

Frequently Asked Questions

Who can join the NCT07015203 clinical trial?

This trial is open to female participants only, aged 18 Years or older, studying Preeclampsia (PE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07015203 currently recruiting?

Yes, NCT07015203 is actively recruiting participants. Contact the research team at Petra.BrlicaHeideova@uzis.cz for enrollment information.

Where is the NCT07015203 trial being conducted?

This trial is being conducted at Most, Czechia, Olomouc, Czechia, Prague, Czechia.

Who is sponsoring the NCT07015203 clinical trial?

NCT07015203 is sponsored by Institute of Health Information and Statistics of the Czech Republic. The principal investigator is Marek Ľubušký, prof. at THE FETAL MEDICINE CENTRE, Department of Obstetrics and Gynecology, Palacky University Olomouc, Faculty of Medicine and Dentistry, University Hospital Olomouc. The trial plans to enroll 2,000 participants.

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