EUCTR2015-005537-50-GB进行中（未招募）1 期
High Or Low Dose Syntocinon® for delay in labour: the HOLDS trial - HOLDS
Birmingham Women's Hospital0 个研究点目标入组 1,500 人开始时间: 2019年11月12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
- 1,500
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
入选标准
- •Inclusion criteria - eligible women will include:
- •- nulliparous women who are able and willing to give informed consent
- •- singleton pregnancy of 37-41 weeks plus 6 days gestation
- •- confirmed delay in labour (using NICE intrapartum care guideline)
- •- ruptured membranes
- •- decision to prescribe syntocinon for augmentation of labour
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Multiparous women
- •Nulliparous women who have reached full dilation of the cervix (10cm)
- •Nulliparpous women undergoing induction of labour
- •Nulliparpous women with a BMI >40 at booking
- •Nulliparpous women who have a multiple pregnancy
- •Nulliparpous women who have existing cardiac disease, bleeding disorders, diabetes (either pre-existing or gestational), scarred uterusprevious uterine surgery,
- •Nulliparpous women with significant antepartum haemorrhage
- •Women are under 16 years of age
- •Women who have a known contra-indication to oxytocin therapy as listed in the Summary of marketing Product Characteristics (SmPC)
研究者
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