Second Generation Low Molecular Weight Heparin (Bemiparin) as a Prophylactic for Management of Subsequent Pregnancy After an Unexplained Stillbirth: A Clinical Comparative Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Stillbirth
研究概览
简要总结
Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound
详细描述
152 women with history of unexplained stillbirths were identified , umbilical arty Doppler ultrasound was conducted for them at 20-22 weeks gestation . they were divided into two group , group one are those with abnormal resistant index (= or more than 0.6) thy received Bemiparin 2500 IU subcutaneously daily up to 24 hours before delivery .
Group 2 with normal umbilical artery resistant index received no any interventions just routine antenatal follow up .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Second pregnancy after previous unexplained fetal death
- •Singleton pregnancy
- •No any medical disorders during pregnancy like diabetes or Systemic Lupus Erythematosus
- •Normally located placenta
- •No congenital fetal anomalies
- •Patient accept to participate
排除标准
- •Confirmed thrombophilia
- •Twin pregnancies
- •Refused to participate
研究组 & 干预措施
Bemiparin group
Women with high resistant index of umbilical artery received the intervention Bemiparin Sodium 2,500 IU anti Xa/0.2 ml solution for injection in pre-filled syringe provided for each woman . The injections were received daily since 20 weeks gestation and up to 24 hours before delivery
Other Name: Hibor; Laboratories Rovi pharmaceuticals
干预措施: Bemiparin (Drug)
control group
Normal umbilical arty resistant index group received only multivitamins and routine antenatal follow up
干预措施: multivitamins and routine antenatal follow up (Other)
结局指标
主要结局
Stillbirth
时间窗: after 20 weeks gestation to the delivery of fetus
Intrauterine fetal death
Early neonatal death
时间窗: First week of life
Death of newborn
Low birth weight
时间窗: first hour of life
New borne with birth weight less than 5th percentile in kilogram
次要结局
- major abruptio placenta(20-41 week gestation)
- Pre-eclampsia(20-41 week gestation)
- Preterm labor(20-37 weeks)
研究者
Shahla Alalaf
professor
Hawler Medical University