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

NCT05284474

Not Yet RecruitingNA

Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Conditions: Fetal Growth Retardation, Preeclampsia, Placenta Diseases

Interventions: soluble fms-like tyrosine kinase to placental growth factor ratio (sFlt-1/PlGF)

Countries: Spain

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 overview

Sex: FEMALE

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Major fetal malformations or genetic disorders
* Fetal death
* Refusal to give informed consent
* Stage IV FGR
Locations (27)
  • A Coruña, Spain
  • Alicante, Spain
  • Badalona, Spain
  • Barcelona, Spain
  • Barcelona, Spain
  • Barcelona, Spain
  • Cadiz, Spain
  • Elche, Spain
  • Getafe, Spain
  • Gijón, Spain
  • Girona, Spain
  • Granada, Spain
  • Jerez de la Frontera, Spain
  • Las Palmas de Gran Canaria, Spain
  • Lleida, Spain
  • Madrid, Spain
  • Palma de Mallorca, Spain
  • Palma de Mallorca, Spain
  • Sabadell, Spain
  • Santa Cruz de Tenerife, Spain
  • Seville, Spain
  • Seville, Spain
  • Tarragona, Spain
  • Terrassa, Spain
  • Terrassa, Spain
  • Torrejón de Ardoz, Spain
  • Zaragoza, Spain