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临床试验/NCT03166111
NCT03166111已完成3 期

Effect of Self-administered Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery: A Randomized Controlled Study

Assiut University1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
216
试验地点
1
主要终点
The difference in pain scores during intrauterine device insertion

研究概览

简要总结

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

lidocaine group

Experimental

lidocaine in-situ gel inserted vaginally

干预措施: lidocaine gel (Drug)

placebo group

Placebo Comparator

placebo gel inserted vaginally

干预措施: placebo gel (Drug)

结局指标

主要结局

The difference in pain scores during intrauterine device insertion

时间窗: 10 minutes

using visual analog scale from 0 to 10

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Abbas

principal investigator

Assiut University

研究点 (1)

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