Management of Fetal Growth Restriction at Term: Angiogenic Factors Versus Feto-placental Doppler (GRAFD Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,088
- 试验地点
- 24
- 主要终点
- Adverse perinatal outcomes
研究概览
简要总结
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.
详细描述
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.
- 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).
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women ≥ 16 years of age.
- •Singleton pregnancy.
- •Ultrasonographic estimated fetal weight <10th centile.
- •Gestational age between 36+0 and 37+6 weeks.
排除标准
- •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 ≤
- •Oligohydramnios
- •Refusal to give informed consent.
结局指标
主要结局
Adverse perinatal outcomes
时间窗: 4-6 weeks
Cesarean delivery for non-reassuring fetal status or neonatal acidosis (artery cord potential of hydrogen (pH) \<7.15 + base excess \> -12 milliequivalent/L)
次要结局
- Rate of Cesarean delivery(4-6 weeks)
- Rate of total deliveries at <37, <38, <39 and <40 weeks of gestation(4-6 weeks)
- Rate of Induction of labor(4-6 weeks)
- Rate of neonatal complications(4-10 weeks)
- Rate of maternal complications(4-6 weeks)
- Rate of elective delivery(4-6 weeks)
- Time of neonatal admission in intensive care unit(4-6 weeks)
- Rate of preeclampsia(4-6 weeks)
- Rate of neonatal admission in intensive care unit(4-6 weeks)
- Rate of perinatal complications(4-6 weeks)
- Rate of elective deliveries at <37, <38, <39 and <40 weeks of gestation(4-6 weeks)
- Rate of newborns with birthweight <2000 and <2500 grams(4-6 weeks)