Management of Early-onset Fetal Growth Restriction: Angiogenic Factors Versus Feto-placental Doppler

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

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

340 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital Universitari Vall d'Hebron Research Institute

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Roche Diagnostics GmbH

Collaborator