NCT04502823

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,088 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Fetal Growth Retardation

Interventions

Type	Name	Description
PROCEDURE	Management based on sFlt-1/PlGF values	In women allocated to the intervention group, the 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 immediately (within 24h) at ≥37 weeks. * Fetuses with sFlt-1/PlGF \<38 weekly follow up will be recommended and delivery at ≥40 weeks.

Timeline

• Start date: 2020-09-21
• Primary completion: 2022-12-18
• Completion: 2022-12-18
• First posted: 2020-08-06
• Last updated: 2024-02-21

Locations

20 sites across 1 country: Spain