Enoxaparine en PREvention Des insuffiSAnces Placentaires Chez Les Femmes eNCEintes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Incidence of retroplacental hematoma (RPH)
研究概览
简要总结
Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant women.
详细描述
Randomized, prospective, monocentric, open-label comparative study with two parallel groups (Enoxaparin, at a preventive dose, combined with Aspirin versus Aspirin alone), with the main objective being to evaluate the effectiveness of enoxaparin, at a preventive dose, in reducing placental insufficiency during pregnancy in pregnant women.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and
- •Age ≤ 45 years and
- •Single and confirmed pregnancy and
- •Intrauterine growth restriction (IUGR) history with an estimated fetal weight (ESW) < 3rd percentile and / or
- •In utero fetal death (IUFD) history > 12 weeks of amenorrhea (WA) and / or
- •Central Retroplacental hematoma (RPH) history < 34 WA and / or
- •History of severe preeclampsia < 34 WA and
- •Informed consent, written and obtained
排除标准
- •Age <18 years or
- •Age > 45 years or
- •Multiple pregnancy or
- •Pregnancy > 7 WA or
- •Positive immunological assessment or
- •Known history of Thromboembolic diseases, Hemorrhagic diseases, Systemic Lupus Erythematosus (SLE), Heparin-induced thrombocythemia (HIT), Suspicion of thrombophilia (burdened history) or an episode of Deep Vein Thrombosis (DVT) or
- •Anticoagulation required or
- •Thrombocythaemia < 100,000 plq / µl or
- •Weight > 100 kg or
- •Osteoporosis or
- •Known allergy to the study products or
- •Inability to ensure injections' administration or
- •Family history of DVT before 40 years of age or
研究组 & 干预措施
Arm 1
Patients going on ASPIRIN 100 mg/day combined with ENOXAPARIN 4000 IU per dat prevention treatment according to randomization:
- Administer Aspirin 100 mg Oral Tablet, Enteric Coated once daily
- Administer the Enoxaparin preventive dose of 4000 IU as a subcutaneous Enoxaparin 40 mg / 0.4 mL Prefilled Syringe once daily
- Start treatment from inclusion visit
- Maintain treatment until the day of delivery, or the appearance of a complication (Retroplacental hematoma (RPH), preeclampsia (PE) , In utero fetal death (IUFD), or Intrauterine growth restriction (IUGR) and its complications)
干预措施: Enoxaparin 40 mg / 0.4 mL Prefilled Syringe (Drug)
Arm 1
Patients going on ASPIRIN 100 mg/day combined with ENOXAPARIN 4000 IU per dat prevention treatment according to randomization:
- Administer Aspirin 100 mg Oral Tablet, Enteric Coated once daily
- Administer the Enoxaparin preventive dose of 4000 IU as a subcutaneous Enoxaparin 40 mg / 0.4 mL Prefilled Syringe once daily
- Start treatment from inclusion visit
- Maintain treatment until the day of delivery, or the appearance of a complication (Retroplacental hematoma (RPH), preeclampsia (PE) , In utero fetal death (IUFD), or Intrauterine growth restriction (IUGR) and its complications)
干预措施: Aspirin 100 mg Oral Tablet, Enteric Coated (Drug)
Arm 2
Patients going on ASPIRIN 100 mg/day prevention treatment alone according to randomization:
- Administer only Aspirin 100 mg Oral Tablet, Enteric Coated once daily
- Administer orally
- Start treatment from inclusion visit
- Maintain treatment until 35 Weeks of Amenorrhea (WA)
干预措施: Aspirin 100 mg Oral Tablet, Enteric Coated (Drug)
结局指标
主要结局
Incidence of retroplacental hematoma (RPH)
时间窗: 7 - 42 weeks of amenorrhea
To compare the incidence of RPH between the two arms of the study.
Incidence of intrauterine growth restriction (IUGR)
时间窗: 7 - 42 weeks of amenorrhea
To compare the incidence of IUGR between the two arms of the study.
Incidence of maternal death
时间窗: 7 - 42 weeks of amenorrhea
To compare the incidence of maternal death between the two arms of the study.
Recurrence rate of preeclampsia
时间窗: 7 - 42 weeks of amenorrhea
To compare the recurrence rate of preeclampsia between the two arms of the study.
Incidence of perinatal death
时间窗: 7 - 42 weeks of amenorrhea
To compare the incidence of perinatal death between the two arms of the study.
次要结局
- Number of adverse events(7 - 42 weeks of amenorrhea)
- Incidence of neonatal death(From birth to 28 days of life)
- Incidence of miscarriage(13 - 21 weeks of amenorrhea)
- Incidence of in utero fetal death (IUFD)(22 weeks of amenorrhea at birth)