Combined Sonographic Examination and Placenta Protein 13 (PP13) to Compare the Risk for Development of Preeclampsia Among Among Pregnant Women With and Without a History of Preterm Delivery and Those Treated by Progesterone or Clexane
试验速览
- 阶段
- 2 期
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection
研究概览
简要总结
Assessment of biochemical and sonographic marker to predict the risk for developing preeclampsia Among biochemical markers are serum level of Placental Protein 13 (PP13) and Placenta Growth factor (PIGF). For sonographic marker Doppler pulsatility Index of the blood flow through the uterine maternal arteries is assessed.
PP13 is produced by the placenta and released to the maternal blood circulation. It has been shown to be an effective serum marker for early onset preeclampsia (Nicolaides KH et al., 2005). The purpose of this study is to combined the assessment of the biochemical markers with Doppler in the first and the second trimester to provide a comprehensive evaluation of various methods for sequential and combined analysis to assess the risk for developing preeclampsia.
详细描述
This is a prospective observational study enrolling all comers who attend the prenatal clinic for first trimester assessment of the risk for Down syndrome. All women are providing medical and obstetric history, demography and blood samples along with Doppler pulsatility Index during the first and the second trimester at GA 10-13 weeks and 21-23 weeks. When possible - blood will be drawn at hospital admission for delivery. Measurements of sonography and serum markers are done blinded to pregnancy outcome.
Patients will be assigned to three groups:
- All comers attending the prenatal testing at GA 10-13.
- Patients with a history of at least 2 pregnancy loss or preterm delivery and treated with low molecular weight heparin at 40-80 mg/day from admission to until 12 weeks after delivery.
- Patients who admitted the emergency ObGyn clinic for bleeding during the first trimester and are treated with progesterone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 16-45 with viable pregnancy as defined by CRL and after signing on an informed consent
- •In group 1 all patients meeting the above are eligible when GA is below 14 weeks
- •In grop 2 all patients
排除标准
- •Gestation age at enrolment > 13 weeks and 6 days by LMP verified by ultrasound at blood taking
- •Mental retardation or other mental disorders that impose doubts regarding the patient's true willingness to participate in the Study
研究组 & 干预措施
1
Control not treated, no placebo
干预措施: No Drug (Drug)
2
Patient treated with low molecular weight heparin after repeated pregnancy loss
干预措施: Low molecular weight Heparin (Drug)
3
Patient super from first trimester bleeding treated with progesterone
干预措施: Progesterone (Drug)
结局指标
主要结局
Preeclampsia (hypertension >140/90, proteinuria >2+ or 300 mg/Dl in 24 hr collection
时间窗: pregnancy week >20 till 41 weeks
次要结局
- intra uterine growth restriction, preterm delivery, spontaneous abortion and Intra uterine fetal death(fron conception to until a week after delivery)