EUCTR2013-005398-32-GB进行中(未招募)1 期
A randomised controlled trial of sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction - STRIDER version 2.0
iverpool Women's NHSFT0 个研究点目标入组 112 人开始时间: 2015年2月9日最近更新:
适应症
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
- 112
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
- •1) Women with singleton pregnancy and fetus diagnosed with severe, early onset intrauterine growth restriction (IUGR) between 22+0 and 29+6 weeks of gestation and clinical decision to manage pregnancy expectantly.
- •2) IUGR is defined as estimated fetal weight or abdominal circumference <10th centile and absent or reversed end diastolic velocity Doppler in the umbilical artery.
- •3) 16 years of age or older
- •4) Consent to take part in the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 112
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) Multiple pregnancy
- •2) Known or suspected structural or chromosomal fetal abnormality
- •3) Maternal illness (eg pre-eclampsia) thatis expected to require delivery for maternal reasons within the next 72 hours
- •4) Maternal wish not to have active management of the pregnancy, or to have pregnancy termination weeks
- •5) Inability to give informed consent
- •6) Cocaine use
- •7) Contraindication to sildenafil therapy, eg known maternal cardiac disease, left ventricular outflow tract obstruction, concommitant treatment with nitrates or previous allergy to sildenafil
研究者
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