Can Treatment With Low Molecular Weight Heparin During Pregnancy With Intrauterine Growth Restriction Increase Birth Weight?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- birth weight
研究概览
简要总结
The purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.
详细描述
Clinical purpose:
- To examine whether treatment with low molecular weight heparin in pregnant women with Intrauterine Growth Restriction (IUGR)increases the birth weight of the child. Our hypothesis is that an increased birth weight leads to reduced morbidity and mortality among these children.
Laboratory purposes:
- To evaluate three new methods to monitor the effect of LMWH.
- To investigate if 2 biochemical markers are positive predictors of IUGR IUGR is defined as a foetus that grows less than expected. IUGR is estimated to occur in up to 5% of all pregnancies, and IUGR is the second most common cause of perinatal morbidity and mortality. Thus, 75% of all stillbirths are caused by IUGR. IUGR is diagnosed by ultrasonography. In IUGR the uteroplacental blood flow is often compromised resulting in foetal growth restriction.
Design: The study is a prospective randomised study where pregnant women with suspected severe IUGR are randomised either to treatment with Innohep® or no treatment. Half of the women receive Innohep® and half of the women do not receive treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Singleton pregnancy
- •IUGR shown by ultrasonography:
- •Can understand and read Danish
排除标准
- •Age below 18 years
- •Pregestational weight < 90 kilograms
- •Not able to give informed consent
- •Chronic kidney disease with creatinine >150 μmol/l
- •Chronic hypertension with blood pressure >140/90 mmHg
- •Diabetes mellitus; type 1 or 2 or gestational diabetes
- •Inflammatory bowel disease
- •Severe heart disease (including mechanical heart valves)
- •Drug or alcohol abuse
- •Known coagulopathy (von Willebrand disease, thrombocytopenia, carrier of haemophilia)
- •Treatment with vitamin K antagonists
- •Known allergy to low LMWH
- •Previous heparin-induced thrombocytopenia (HIT (type II))
- •Clinically significant bleeding within the last month
- •Women with indication for prophylactic treatment with LMWH during pregnancy e.g. previous thromboembolic disease or serious types of thrombophilia (deficiency of antithrombin, protein C or protein S)
- •Chromosome anomaly in the child
- •Severe malformations in the child
- •Contraindication to Innohep®
- •Gestational week > 32 weeks
研究组 & 干预措施
Innohep
Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37
干预措施: Innohep (Tinzaparin) (Drug)
Innohep
Tinzaparin 4500 I.U. sub cutaneous once daily until gestational week 37
干预措施: tinzaparin (Drug)
结局指标
主要结局
birth weight
时间窗: Birth weight registered at birth
We compare birth weight in children born of women from the 2 study arms
次要结局
- maternal morbidity(Comorbidity registered up to one year after birth)