Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Fetal Growth Retardation

Clinical Trial Details

NCT number	NCT04502823
Study type	Interventional
Source	Hospital Universitari Vall d'Hebron Research Institute
Contact
Status	Completed
Phase	N/A
Start date	September 21, 2020
Completion date	December 18, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms