Clinical trial NCT07015203: The Combined First Trimester Screening
Official title: The Combined First Trimester Screening
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Preeclampsia (PE)
Fetal Growth Restriction
Congenital Abnormalities
Preterm Labor
Intrauterine Fetal Demise
Genetics Syndrome
Pregnancy Overdue - Week 41+6
Keywords: preeclampsia
prediction
prevention
maternal risk factors
Mean Arterial Pressure
Uterine artery Pulsatility Index
Placental Growth Factor
acetylsalicylic acid
Czech Republic
Lead sponsor: Institute of Health Information and Statistics of the Czech Republic
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital Olomouc
name: Institute for the Care of Mother and Child, Prague, Czech Republic
name: Krajská zdravotní, a.s. - Nemocnice Most, o.z.
First posted: 2025-06-11
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women matching all inclusion criteria \& GDPR.

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Proportion of women with identified increased risk of Preeclampsia, Fetal Growth Restriction or Fetal Chromosomal Aneuploidies (trisomies of chromosomes 21, 18 and 13)
timeFrame: From June 2025 to October 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Most
country: Czechia
facility: Regional Health Corpotarion - Most Hospital
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
city: Prague
country: Czechia
facility: Institute for the Care of Mother and Child
Study officials:
affiliation: THE FETAL MEDICINE CENTRE, Department of Obstetrics and Gynecology, Palacky University Olomouc, Faculty of Medicine and Dentistry, University Hospital Olomouc
name: Marek Ľubušký, prof.
role: STUDY_DIRECTOR
References: