Single Scan Screening of Fetal Growth Restriction Versus Longitudinal Scan Screening in the Third Trimester: a Multicenter Randomized Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 813
- 试验地点
- 2
- 主要终点
- Rate of Small for Gestational Age at Birth Identified Antenatally
研究概览
简要总结
The aim of this trial is to assess the efficacy of two screening protocols for the detection of fetal growth disorders.
In Italy at the moment the screening protocol should not be universal but only on clinical indications. In some Regions the screening is offered to every pregnant women with an early third trimester scan at 28-32 weeks'gestation or, in other Regions, according to the new national recommandations, a growth scan during the third trimester is provided only if there is a clinical indication.
详细描述
The Aim of this trial is to assess the efficacy and efficiency of two screening protocols for fetal growth disorders: one providing an early fetal growth assessment at 28-32 weeks' (single scan) and the second one with the addition of a late third trimester screening at 35-37 weeks (longitudinal scan).
This study is designed to generate level 1 evidence of diagnostic efficacy.
MAIN OUTCOME: The main outcome of the two protocols in screening true late SGA fetuses is measured based on the antenatal detection of small for gestational age newborn basing on the IG21th newborn weight charts centiles <the 10th according to gestational age and gender at delivery.
SECONDARY OUTCOME
- Antenatal detection of severe SGA <3rd centile
- Mode of delivery
- Caesarean section rate according to Robson classes for singleton
- Composite mild adverse neonatal outcome (Apgar score at 5 minutes <7, pH < 7.10, or BD >8mmol/L, admission at NICU)
- Composite severe adverse perinatal (stillbirth or term live birth associated with neonatal death, hypoxic ischaemic encephalopathy, use of inotropes, need for mechanical ventilation, or severe metabolic acidosis (defined as a cord blood pH <7•0 and base deficit >12 mmol/L)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligible cases are nulliparous pregnant women, with first trimester ultrasound assessment of gestational age, who conceived singleton fetuses. If the crown-rump-length (CRL) differs of more than ± 3-5 days from the last menstrual period, gestational age is calculated on the CRL.
排除标准
- •major medical disease
- •high risk for preeclampsia on history or detected in those centres that perform pre-eclampsia screening at first trimester
- •women older than 40 years on ASA low dose prophylaxis
- •known immune disorders or clinical thrombophilic conditions;
- •twin pregnancies;
- •suspected fetal anomalies at any gestational age
- •Papp-A at Combined-Test<0.2
结局指标
主要结局
Rate of Small for Gestational Age at Birth Identified Antenatally
时间窗: at birth
Rate of newborns with a Birth Weight \<10 th centile according to International Prescriptive Charts who were prenatally identified
次要结局
- Rate of Cesarean Section in the Two Groups(at birth)
- Rate of Adverse Outcomes(up to 40 days after birth)