NCT01388322已完成3 期
Enoxaparin for the Prevention of Placental-Mediated Complications of Pregnancy in Women With Obstetric History or Abnormal Uterine Artery Doppler at First Trimester Ultrasound and Without Thrombophilia: a Multicenter Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 361
- 试验地点
- 4
- 主要终点
- Development of any of these complications of placental insufficiency
研究概览
简要总结
This is a Multicenter, randomized, open-label, parallel groups study to test the hypothesis that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks of gestation could improve maternal and perinatal outcome in women at high risk for developing placental-mediated pregnancy complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Pregnant women ≥18 years
- •Gestational age < 14 weeks at randomisation
- •One or more of the following complications in a previous pregnancy:
- •Severe PE resulting in delivery before 32 weeks of gestation
- •Newborn weight less than the 10th percentile and documented abnormal Doppler in the umbilical artery during pregnancy before 32 weeks gestation
- •Abruption of placenta
- •Unexplained intrauterine death between 20-41,6 weeks of gestation secondary of placental insufficiency or
- •Uterine arteries Pulsatility Index (mPI) Doppler ≥95th percentile at 11-14 weeks of gestation.
排除标准
- •Multiple pregnancy
- •Abnormal thrombophilia study
- •Alcohol or illicit drug use
- •Severe fetal malformations or chromosomal abnormalities
- •Previous history of infertility ( 3 or more early miscarriages)
- •Maternal HIV, Cytomegalovirus or toxoplasma infection
- •Known fetal abnormality or chromosomal defect at randomisation
- •Women with previous venous or arterial thrombotic event
- •Organic lesions that could increase the hemorrhagic risk: gastric ulcus, stroke, a recent hemorrhagic event, high risk situations for hemorrhagic event
- •Known allergy to heparin or LMWH, thrombopenia or thrombosis episode due to heparin treatment
- •Contraindication to LMWH
- •An absolute indication for anticoagulant therapy: venous deep thrombosis, pulmonary embolism, ovaric hyperestimulation, cardiophaty, others
- •Metabolic disorders a risk for development of PE and/or IUGR: Type I diabetes, hipertiroidism, chronic renal insufficiency
研究组 & 干预措施
Enoxaparin
Experimental
Subcutaneous administration of one dose daily of enoxaparin
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Development of any of these complications of placental insufficiency
时间窗: from date of randomization until the date of delivery (assessed up to 30 weeks)
Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise
次要结局
- Neonatal Data(after the delivery (an expected average of one month))
- Days of hospitalization during pregnancy(from randomization to the time of delivery (30 weeks))
- Gestational age at birth(from date of randomization until the date of delivery (assessed up to 30 weeks))
- Days of maternal hospitalization in the postpartum period(from delivery until discharge (an expected average of one week))
研究者
研究点 (4)
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