NCT01617564已完成不适用
Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial
Kristina Gemzell Danielsson2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
Paracervical blockage can reduce severe pain during second trimester induced medical abortion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who request second trimester medical abortion (13-22 weeks gestation according to ultrasound)
- •18 years of age or older
- •able to understand and communicate in Swedish
- •able to understand the study related information and willing to give her
- •informed consent to participation in the study
排除标准
- •Known allergy to bupivakain or related substances
研究组 & 干预措施
Bupivacain
Active Comparator
干预措施: bipuvacain (Drug)
Sodium Chloride
Sham Comparator
干预措施: NaCl (Other)
结局指标
主要结局
Pain score
时间窗: at 24 hours
Pain indicated on VAS at specific time intervals during the induction to expulsion
次要结局
- Efficacy(after 24h from induction)
- Time to abortion(at 24hours)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(at 6 to 8 weeks)
研究者
Kristina Gemzell Danielsson
Professor
Karolinska Institutet
研究点 (2)
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