ISRCTN39133303已完成3 期
A randomised controlled trial of sildenafil therapy in dismal prognosis early-onset intrauterine growth restriction
iverpool Women's NHS Foundation Trust (UK)0 个研究点目标入组 112 人开始时间: 2014年7月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
研究概览
简要总结
- 2014 protocol in https://www.ncbi.nlm.nih.gov/pubmed/24618418 2. 2017 protocol in https://www.ncbi.nlm.nih.gov/pubmed/29282009 3. 2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30169244
研究设计
- 研究类型
- Interventional
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
排除标准
- •1. Multiple pregnancy
- •2. Known or suspected structural or chromosomal fetal abnormality
- •3. Maternal illness (e.g., pre-eclampsia) that is 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, e.g., known maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil
研究者
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