About this trial
This is a multicentre, open-label, randomized controlled trial. A total of 340 singleton pregnancies with an EFW ≤10th percentile between 26+0 and 31+6 weeks will be recruited and randomly allocated to either the control or the intervention group. In the control group, standard Doppler-based management will be used. In the intervention group, different soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF) cutoffs will be incorporated to the current protocol to adjust the frequency of ultrasounds and to plan elective delivery.
Eligibility criteria
Qualifiers
Pregnant women of at least 18 years old
Singleton pregnancy
Ultrasonographic EFW ≤10th percentile between 26+0 and 31+6 weeks of gestation
Gestational age confirmed by fetal crown-rump length measurement during the first trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates.
Disqualifiers
Major fetal malformations or genetic disorders
Fetal death
Refusal to give informed consent
Stage IV FGR
Trial design
Treatments tested in this trial
- soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF)
Treatment groups
Sponsors and collaborators
Hospital Universitari Vall d'Hebron Research Institute
Lead sponsor
Instituto de Salud Carlos III
Collaborator
Roche Diagnostics GmbH
Collaborator