The Combined First Trimester Screening
Recruiting · NCT07015203 · Observational (researchers observe without assigning treatment) · Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
3 locations listed.
- Regional Health Corpotarion - Most Hospital - Most, Czechia, Czechia
- University Hospital Olomouc - Olomouc, Czechia, Czechia
- Institute for the Care of Mother and Child - Prague, Czechia, Czechia