Angiogenic Markers for Confirming Term Preeclampsia (noPE-37 Trial): An Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 23
- 主要终点
- Composite maternal outcome
研究概览
简要总结
This study tests the hypothesis that, in women with preeclampsia without severe features, delivery management based on sFlt-1/PlGF would reduce the rate of induction of labor without worsening the rate of progression to preeclampsia with severe features and other maternal complications.
详细描述
Participants with preeclampsia without severe features between 36 and 38+6 weeks, who do not meet any exclusion criteria, will be randomly assigned to two groups:
- In the study group, if angiogenic factors are normal (sFlt-1/PlGF <38), delivery will be delayed until 39 weeks; if any other medical condition is present, delivery will be scheduled according to the specific protocol for it.
- In the study group, if angiogenic factors are abnormal (sFlt-1/PlGF ≥38), labor will be induced at ≥37 weeks.
- In the control group, labor will be recommended at 37 weeks, as is currently standard.
- In both groups, NT-proBNP levels will be measured at enrollment.
- In both groups, a satisfaction questionnaire will be completed at enrollment and 4 weeks after delivery.
- In both groups, if any of the following is present, delivery will be recommended immediately (within 24 hours):
- preeclampsia with severe features according to ACOG criteria
- decreased fetal movements
- absent or reversed diastolic flow in the umbilical artery
- non-reassuring CTG
- biophysical profile score ≤6
- oligohydramnios (largest vertical pocket <2 cm)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Singleton pregnancy
- •Preeclampsia without severe features according to the ACOG definition
- •Antegrade diastolic flow in the umbilical artery Doppler
- •Gestational age between 36+0 and 38+6 weeks of gestation
- •Gestational age confirmed by fetal crown-rump length measurement in the first-trimester scan (from 11+0 to 13+6 weeks of gestation) or by in vitro fertilization dates
排除标准
- •Fetal death
- •Preeclampsia with severe features according to the ACOG definition, eclampsia, or any condition that requires immediate delivery
- •Absent or reversed end-diastolic flow in the umbilical artery Doppler
- •Non-reassuring CTG
- •Decreased fetal movements
- •Biophysical profile score ≤6
- •Oligohydramnios
- •Refusal to provide informed consent
- •Fetal malformation
- •Placental abruption
- •Antiphospholipid antibody syndrome
研究组 & 干预措施
Standard care: elective delivery at 37 weeks of gestation
In the control group, a blood test to assess the sFlt-1/PlGF ratio will be performed, and the result will be concealed from investigators. As in current clinical practice, elective delivery will be scheduled at 37 weeks. If preeclampsia is first diagnosed after 37 weeks, immediate delivery will be recommended. If at any time after enrollment any of the following is present, immediate delivery (within 24 hours) will be recommended: preeclampsia with severe features according to ACOG criteria, decreased fetal movements, absent or reversed diastolic flow in the umbilical artery, non-reassuring CTG, biophysical profile score ≤6, or oligohydramnios.
干预措施: Standard care: elective delivery at 37 weeks of gestation (Other)
Intervention arm: expectant management if sFlt-1/PlGF<38
If sFlt-1/PlGF <38, expectant management will be followed until 39 weeks. If any other medical condition is present, local protocols for the specific condition will be followed. If fetal growth restriction in present (with antegrade diastolic umbilical flow), weekly repetition of sFlt-1/PlGF wil be done. If sFlt-1/PlGF ≥38, delivery at 37 weeks will be recommended, or immediate delivery if the patient is enrolled after 37 weeks. If at any time after enrollment any of the following is present, immediate delivery (within 24 hours) will be recommended: preeclampsia with severe features according to ACOG criteria, decreased fetal movements, absent or reversed diastolic flow in the umbilical artery, non-reassuring CTG, biophysical profile score ≤6, sFlt-1/PlGF ≥38 or oligohydramnios.
干预措施: Intervention arm: expectant management if sFlt-1/PlGF<38 (Other)
结局指标
主要结局
Composite maternal outcome
时间窗: through study completion, an average of 2 months
The primary outcome is a composite poor maternal outcome, defined as maternal mortality, severe maternal morbidity (eclampsia, HELLP syndrome, thromboembolic disease, pulmonary edema, or placental abruption), preeclampsia with severe features, and major postpartum hemorrhage (\>1000 mL).
次要结局
- Neonatal morbidity(through study completion, an average of 2 months)
- Method of delivery(through study completion, an average of 2 months)
- Maternal admission to ICU(through study completion, an average of 2 months)
- Days of maternal admission to ICU(through study completion, an average of 2 months)
- Gestational age at delivery(through study completion, an average of 2 months)
- Birthweight(through study completion, an average of 2 months)
- Birthweight percentile(through study completion, an average of 2 months)
- Prematurity(through study completion, an average of 2 months)
- Days of neonatal admission to NICU(through study completion, an average of 2 months)
- Metabolic acidosis(through study completion, an average of 2 months)
- Need of maternal corticosteroids(through study completion, an average of 2 months)
- Maternal NT-proBNP levels(through study completion, an average of 2 months)
- Maternal satisfaction measured by the Generic Short Patient Experiences Questionnaire (GS-PEQ)(through study completion, an average of 2 months)
- Neonatal morbidity(through study completion, an average of 2 months)
- Method of delivery(through study completion, an average of 2 months)
- Maternal admission to ICU(through study completion, an average of 2 months)
- Days of maternal admission to ICU(through study completion, an average of 2 months)
- Gestational age at delivery(through study completion, an average of 2 months)
- Birthweight(through study completion, an average of 2 months)
- Birthweight percentile(through study completion, an average of 2 months)
- Prematurity(through study completion, an average of 2 months)
- Days of neonatal admission to NICU(through study completion, an average of 2 months)
- Metabolic acidosis(through study completion, an average of 2 months)
- Need of maternal corticosteroids(through study completion, an average of 2 months)
- Maternal NT-proBNP levels(through study completion, an average of 2 months)
- Maternal satisfaction measured by the Generic Short Patient Experiences Questionnaire (GS-PEQ)(through study completion, an average of 2 months)