EUCTR2006-005839-20-SE进行中（未招募）不适用
A randomised, double-blind, placebo-controlled, multicentre trial to access the safety and efficacy of pre-treatment with DF01 during late pregnancy in reducing prolonged labour.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Dilafor AB
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •a) Healthy nulliparous females, 18-40 years of age with the gestation age confirmed by ultrasound.
- •b) Normal singleton pregnancy
- •c) Intact membranes
- •d) In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits.
- •e) Subject is capable of understanding and signing an informed consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a) Breech presentation including other abnormal presentations
- •b) Vaginal bleeding in the last 10 weeks of the pregnancy
- •c) Intercurrent illness (e.g. essential hypertension, diabetes, coagulation disorders)
- •d) Pregnancy complications (e.g. hypertension in pregnancy, preeclampsia, hepatosis)
- •e) Coagulation defects (prolonged APTT; Prothrombin complex (INR) > 1.2 ); Thrombocytes <130 x 109/L
- •f) Infections (HIV, hepatitis, STDs)
- •g) Suspected foetal malformation
- •h) Suspected intrauterine growth retardation
- •i) Hospitalized due to complication during the last 10 weeks of the pregnancy
- •j) Any known history of allergy to heparin and/or dalteparin (Fragmin)
- •k) Any known history of heparin-induced thrombocytopenia
- •l) Fear of injections
- •m) Body mass index (BMI) > 30 kg/m2.
研究者
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