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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    1030
  • sponsor
    Hospital Universitari Vall d'Hebron Research Institute
Updated on 17 September 2021

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 Intrauterine Growth Retardation, iugr, fetal growth restriction, fetal growth retardation, intrauterine growth restriction
Treatment Management based on sFlt-1/PlGF values
Clinical Study IdentifierNCT04502823
SponsorHospital Universitari Vall d'Hebron Research Institute
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pregnant women 16 years of age
Singleton pregnancy
Ultrasonographic estimated fetal weight <10th centile
Gestational age between 36+0 and 37+6 weeks

Exclusion Criteria

Major fetal malformations or genetic disorders
Fetal death
Absent or reverse end-diastolic flow in umbilical artery Doppler or DV PI>95th centile
Non-reassuring cardiotocography (CTG)
Preeclampsia
Diminished fetal movements
Biophysical profile 6
Oligohydramnios
Refusal to give informed consent
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