Biobank of Data and of Human Biological Samples on Prematurity, Preeclampsia and Other Pregnancy Complications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7,845
- 试验地点
- 1
- 主要终点
- early onset preeclampsia
研究概览
简要总结
The Biobank includes data and biological specimens of women from three original studies: 1) First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3) Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and 4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following Combined Iterative Screening.
详细描述
This Biobank is comprised of: 1) medical, social, obstetrical and ultrasonographic data, 2) human biological samples (maternal plasma, serum and buffy coat, maternal urine, cord blood) and 3) the results derived from these (biochemical or ultrasonographic markers, genetics, risk calculations ...)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •(specific to each study)
排除标准
- •pregnant women <18 years old at recruitment
- •negative fetal heart at recruitment
- •women not able to provide an informed consent to the study
结局指标
主要结局
early onset preeclampsia
时间窗: diagnosed between 20 and 34 weeks of gestation
Preeclampsia will be defined according to the Canadian Guidelines for Diagnosis, Evaluation, and Management of the Hypertensive Disorders of Pregnancy guidelines, as de novo hypertension with diastolic blood pressure \>90 mmHg on two occasions at least four hours apart, after 20 weeks of pregnancy, associated with proteinuria ≥300 mg/24 h or at least '2 +' protein on urine dipstick or an adverse conditions
次要结局
- Fetal aneuploidies(diagnosed during or after pregnancy)
- Severe preeclampsia(between 20 and 42 weeks of gestation)
- spontaneous preterm birth(between 20 and 36 6/7 weeks of gestation)
- Fetal growth restriction(between 20 and 42 weeks of gestation)
研究者
Emmanuel Bujold
Professor
CHU de Quebec-Universite Laval