Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler (GRAFD)

  • STATUS
    Recruiting
  • participants needed
    1030
  • sponsor
    Hospital Universitari Vall d'Hebron Research Institute
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Updated on 30 January 2023
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Summary

Open randomized non-inferiority controlled trial to examine the use of angiogenic factors (instead of feto-placental Doppler) for fetal growth restriction at term to reduce the rate of labor inductions, without worsening perinatal outcomes.

Description

Pregnant women with estimated fetal weight (EFW) < 10th centile between 36+0 and 37+6 weeks of gestation (WG) will receive complete ultrasonographic assessment consisting of feto-placental Doppler, amniotic fluid measurement and biophysical profile assessment. The cases not meeting any exclusion criteria will be offered to participate in this trial. After giving their informed consent a blood sample will be drawn in all of them and they will undergo randomization into two arms.

  1. Intervention arm: In women allocated to the intervention group, the soluble fms-like tyrosine kinase/placental growth factor (sFlt-1/PlGF) result will be revealed to the investigators that will act according to the results of sFlt/PlGF:
    • Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended at ≥37 weeks.
    • Fetuses with sFlt-1/PlGF <38, weekly follow up will be recommended until delivery (at ≥40 weeks).
  2. Control arm: In women allocated to the control group, the sFlt-1/PlGF result will be blinded to caregivers. Routine Doppler-based clinical care will be used to counsel women. Following the Doppler classification:
    • Fetuses with EFW below the 3rd centile or below the 10th centile accompanied by any impaired fetoplacental Doppler, elective delivery will be recommended at at ≥37 weeks.
    • Fetuses with EFW above the 3rd centile without any fetoplacental Doppler abnormality, elective delivery will be recommended at at ≥40 weeks.

In both arms, fetuses will receive weekly follow-up from randomization to delivery consisting on feto-placental Doppler sFlt-1/PlGF and CTG. If any of the following is present at any time, earlier delivery will be recommended:

  • sFlt-1/PlGF ≥38 (only in the intervention group),
  • absent or reverse end-diastolic flow at the umbilical artery Doppler or DV PI>95th centile
  • non-reassuring CTG
  • preeclampsia
  • diminished fetal movements
  • biophysical profile ≤ 6 or oligohydramnios (deepest pocket <2 cm).

Details
Condition Fetal Growth Retardation
Treatment Management based on sFlt-1/PlGF values
Clinical Study IdentifierNCT04502823
SponsorHospital Universitari Vall d'Hebron Research Institute
Last Modified on30 January 2023

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