Diclofenac Potassium With or Without Vaginal Dinoprostone Prior to Hysterosalpingography in Primarily Infertile Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mean pain score during hysterosalpigography by visual analog scale
研究概览
简要总结
The aim of our study is to determine the efficacy of oral diclofenac potassium with or without vaginal dinoprostone prior to hysterosalpingography in primarily infertile patients on the pain scores during HSG.
详细描述
hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind placebo controlled trial
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primary infertility female came for HSG
排除标准
- •any patient has contraindication to HSG
研究组 & 干预措施
Group A
patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure
干预措施: diclofenac potassium + dinoprostone (Drug)
Group B
patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure
干预措施: diclofenac potassium + placebo (Drug)
结局指标
主要结局
Mean pain score during hysterosalpigography by visual analog scale
时间窗: 15 minutes
pain during hysterosalpigography assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable
次要结局
- Intensity of pain(30 minutes after the procedure)
研究者
hany farouk
A Professor
Aswan University Hospital