EUCTR2015-005180-16-IT进行中（未招募）1 期
Early vaginal progesterone for the prevention of spontaneous preterm birth in twins: A randomised, placebo controlled, double-blinded trial. - EVENTS
Fundación para la Formación e Investigación Sanitaria0 个研究点目标入组 1,180 人开始时间: 2018年3月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,180
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
- •Age > 18 years;
- •DCDA or MCDA twin pregnancies;
- •Live fetuses at 11-13 weeks of gestation;
- •Fluent in local language (otherwise interpreters will be used);
- •Informed and written consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1180
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Pregnancies complicated by major fetal abnormality identified
- •at the 11-13 weeks assessment, including nuchal translucency
- •thickness >3.5 mm;
- •MCDA twin pregnancies in which there are early signs of twinto-
- •twin transfusion syndrome (TTTS) (20% discordance in
- •crown-rump length [CRL]);
- •Women who are unconscious or severely ill, those with
- •learning difficulties, or serious mental illness;
- •Hypersensitivity to progesterone;
- •Women taking progesterone regularly or at any time within
- •the previous 7 days;
- •Concurrent participation in another drug trial or at any time
- •within the previous 28 days;
- •Severe hepatic dysfunction [AST or ALT >3 times the upper limit
- •of normal (ULN) or bilirubin >2 x ULN], mammary or genital tract
- •carcinoma, thrombophlebitis or thromboembolic disorders
- •Porphyria
- •Cerebral haemorrhage
- •Allergy to sunflower oil, soy lethicin, gelatin, glycerol (E422),
- •titanium dioxide (E171)
研究者
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