congenital anomalies Congenital chromosomal anomalies
Conditions
Interventions
Patients will be asked to participate into the study and, if consent is
obtained, they will be allocated to one of two different care models:
A) US scan at 10 weeks followed by NIPT (care as usual)
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women with singleton pregnancies who choose for NIPT as first trimester screening test will be included in the study. In order to be included women need to give informed consent by signing a written informed-consent form. Ultrasound practicing using Astraia software for data registration will be included.
Exclusion criteria
Exclusion criteria: Women younger than 18 years and incapacitated persons will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify in how many NIPT tests were unable to provide a conclusive result in study arm A versus B. Inconclusive NIPT results/ no results are defined as of the following: *NIPT cannot be performed because of spontaneous fetal loss diagnosed at ultrasound examination *NIPT is correctly performed but gives an inconclusive result *NIPT is not performed because of exclusion criteria identified at ultrasound examination | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to: * Identify the proportion of TOPs in strategies A and B * Identify the timing of termination of pregnancy in fetuses with congenital abnormalities in group A versus group B; OR timing of definitive diagnosis of anomaly in case of test-positive ultrasound result * Investigate whether a difference in dating of the pregnancy exists if the CRL is measured at 10 weeks or at 12-13 weeks gestation * Investigate patient*s preferences for strategies A and B * Identify the most cost-effective screening strategy * Sensitivity and specificity of strategies A and B | — |
Countries
Netherlands
Outcome results
None listed