ISRCTN66445401已完成3 期
Early vaginal progesterone for the preVention of spontaneous prEterm birth iN TwinS: A randomised, placebo controlled, double-blinded trial- EVENTS
Foundation for Health Education & Research (Fundación para la Formación e Investigación Sanitaria)0 个研究点目标入组 1,194 人开始时间: 2015年11月19日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,194
研究概览
简要总结
2021 results in https://pubmed.ncbi.nlm.nih.gov/32598909/ (added 26/01/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Aged 18 years or over
- •2. Dichorionic diamniotic (DCDA) or monochorionic diamniotic (MCDA) twin pregnancies;
- •3. Live fetuses at 11-13 weeks of gestation;
- •4. English or Spanish speaking (otherwise interpreters will be used)
排除标准
- •1. Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks assessment, including nuchal translucency thickness >3.5 mm
- •2. In MCDA twin pregnancies there are early signs of twin-to-twin transfusion syndrome (TTTS) (20% discordance in crown-rump length [CRL] and/or nuchal translucency [NT])
- •3. Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness
- •4. Hypersensitivity to progesterone
- •5. Concurrent participation in another drug trial or at any time within the previous 28 days
- •6. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol
研究者
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