ISRCTN11186205已完成不适用
Three-arm randomised trial of cervical cerclage, arabin pessary and vaginal progesterone to prevent spontaneous preterm birth in asymptomatic women at high-risk of preterm birth: A feasibility study
niversity of Liverpool (UK)0 个研究点目标入组 39 人开始时间: 2016年3月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
研究概览
简要总结
暂无简介。
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 older
- •2. Singleton pregnancy
- •3. Between 16+0 – 24+6 weeks in current pregnancy
- •4. History of previous spontaneous preterm birth (sPTB) or premature rupture of membranes (PPROM) between 16-33+6
- •5. Cervical length at least <3rd centile for gestational age
- •6. History of significant cervical surgery defined as two large loop excision of the transformation zone (LLETZ) procedures or a single knife cone biopsy (KCB) where a clinical decision is made to treat the short cervix
- •7. Clinical equipoise as to what is the best treatment
排除标准
- •1. Known or suspected structural or chromosomal fetal abnormality
- •2. Inability to give informed consent
- •3. Treatment with history indicated cerclage
- •4. Treatment with vaginal progesterone within two weeks of randomisation
- •5. All contraindications to use of progesterone (see protocol 6.2)
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