Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 805
- 试验地点
- 1
- 主要终点
- preeclampsia
研究概览
简要总结
Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". Algorithms to predict those outcomes have been developed by combining maternal characteristics (history, age, BMI, blood pressure), biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another prospective observational study ("PREDICTION study" NCT 02189148) is also ongoing, which aims to validate those algorithms at the first trimester of pregnancy.
Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates, allowing closer monitoring of high-risk patients and potential therapeutics under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes.
详细描述
The objective of this study is to validate the predictive values of biophysical (maternal blood pressure); biochemical (sFlt-1, β-hCG, PlGF, and AFP) and ultrasonographic (cervical length, Doppler, 3D evaluation of the placenta, 3D nasal bone) biomarkers at several timepoints for the prediction of adverse pregnancy outcomes including preterm birth, preeclampsia, fetal growth restriction and intra-uterine fetal death.
These biomarkers will be evaluated at 14-16 weeks, 20-24 weeks and 30-34 weeks. Those specific gestational ages have been selected because they correspond to the typical clinical/hospital visits for prenatal blood and/or ultrasound screening.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •nulliparous pregnant women participating in Prediction study (NCT02189148)
排除标准
- •<18 years old at recruitment;
- •multiple pregnancies;
- •fetal congenital malformation;
- •positive for HIV or hepatitis C;
- •fetal demise at recruitment;
- •women planning a delivery outside the participating hospitals;
- •women not able to provide an informed consent to the study.
结局指标
主要结局
preeclampsia
时间窗: >20 weeks of preeclampsia
1) de novo hypertension with systolic blood pressure ≥ 140 mmHg or diastolic blood pressure \>90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, and 2) associated with proteinuria ≥300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions
次要结局
- Fetal growth restriction(neonatal weight at birth (on the day of birth))
- Preterm birth(between 20-37 weeks of gestation)
- Intra uterine fetal death(from the 20th week of gestation to the moment of birth)
研究者
Emmanuel Bujold
MD, FRCSC
CHU de Quebec-Universite Laval