EUCTR2018-000770-29-IE进行中（未招募）1 期
Investigating the role of early low-dose aspirin in diabetes: A phase III multicentre double-blinded placebo-controlled randomised trial of low-dose aspirin initiated in the first trimester of diabetes pregnancy - IRELAnD
The Rotunda Hospital0 个研究点目标入组 360 人开始时间: 2018年6月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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
- •Ability to comprehend the Patient Information Leaflet and to provide signed and dated informed consent.
- •Willing to comply with all study procedures and be available for the duration of the study
- •Female, age >18 years
- •Singleton pregnancy, ongoing at 11 – 13+6 weeks’ gestation
- •Pre-pregnancy diagnosis of type I or type II diabetes of at least 6 months’ duration
- •Fulfillment of each criterion must be clearly evidenced (in lab reports or correspondence) and/or documented in the medical records.
- •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 360
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Aspirin hypersensitivity (prior bronchospasm/ urticarial/ angioedema with aspirin)
- •Active or recurrent peptic ulceration (2 or more distinct episodes of proven ulceration or bleeding), repetitive gastric symptoms or history of intolerance of NSAIDs
- •Known bleeding diathesis (hypothrombinaemia, haemophilia, von Willebrands’ disease)
- •Multifetal gestation
- •Breastfeeding
- •Severe early-onset preeclampsia in a previous pregnancy
- •Patient already on aspirin at the time of screening
- •Established chronic renal disease (progressive loss of renal function of at least 3 months’ duration), clinically significant liver disorder, hyperuricemia (Gout), glucose-6-phosphate dehydrogenase (G6PD) deficiency or heart failure (This exclusion criterion will be assessed from patient’s medical history not from screening laboratory tests).
- •Blood clotting disorder or treatment with anticoagulants at the time of recruitment or with anti-platelet therapy (Anticoagulants commenced after recruitment will not constitute exclusion from the trial).
- •Macroalbuminuria (24-hour urinary protein 300g or greater, or spot urinary protein/creatinine ratio >0.3 in the first trimester or dipstick proteinuria >/= +2
- •Chronic hypertension (antihypertensive therapy in first trimester)
- •Inability to speak or read English
- •Use of any other medication that would constitute a risk to a patient taking aspirin in the opinion of the investigator ((including Interferon-a and Methotrexate)
- •Inflammatory bowel disease (Crohn’s disease or Ulcerative colitis)
- •Use of any other investigational medicinal product within the previous 30 days
- •The presence of any illness or condition that might interfere with the patient’s ability to comply with the study procedures
- •The presence of any illness or condition (including recent surgery) that renders the patient unsuitable for treatment with aspirin in the opinion of the investigator
- •Hyperemesis gravidarum
研究者
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