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临床试验/NCT01339338
NCT01339338Unknown1 期

Comparison of the Warm and Cold Contrast Media for Hysterosalpingography: a Prospective, Randomized Study

Taizhou Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
发起方
入组人数
300
试验地点
1
主要终点
incidence of vasovagal episodes

研究概览

简要总结

The purpose of this study is to compare the use of warm-media with cold-media in performing hysterosalpingography (HSG).

详细描述

As an essential step of the infertile work-up, hysterosalpingography remains widely used in many country since it was first reported at 1914. Although HSG is a non-invasive and safety procedure, it still has some adverse. Lower abdominal pain and vasovagal episodes are mainly acute reactions to the contrast media of HSG, the later include nausea, Vomit, Sweating, Weakness and even bradycardia, occur in 16-54% of patients undergoing HSG.

Many techniques were developed to reduce adverse reactions or alleviate the pain in using of contrast media, include previous analgesia, pretreatment with corticosteroids and using non-ionic contrast media for HSG. However, in a recently Cochrane's review, reported it lack of benefit for using any pain relief medication in HSG.

Pre-Warming the hands and instruments makes physical examination more comfortable for the patients. Local active warming can valid lessen the acute pelvic pain. Experiences from the peritoneal dialysis and the laparoscopy surgical reveal that warm dialysis solution or air insufflation can decrease the pain of operation. A randomize study on Sonohysterography (SHG), another technique for exam tubal and uterine cavity diseases, cue that warming of Echovist contrast media to body temperature is a simple and effective intervention in reducing discomfort at the time exam.Because the less volume of medium injected during the HSG and the iodine medias may have different properties to the Echovist media, whether this intervention is also valid in HSG remains unknown.

研究设计

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

入排标准

年龄范围
16 Years 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • infertile women who seeking for HSG testing

排除标准

  • suspect of pregnancy
  • acute low reproductive duct infection
  • a known hypersensitivity to iodine
  • genital bleeding
  • genital malignancy

研究组 & 干预措施

warm media

Experimental

Subjects undergo HSG using a warm media heated with a 37℃ water-bathing

干预措施: warming the contrast media (Procedure)

cold media

No Intervention

the contrast media under room temperature without heat

干预措施: warming the contrast media (Procedure)

结局指标

主要结局

incidence of vasovagal episodes

时间窗: from the injection of the media to a half hour after HSG

vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG

次要结局

  • Visual analogue scale pain score during HSG(within the first 30 seconds after the constra media "spill out")
  • Visual analogue scale pain score after HSG(a half hour after HSG)

研究者

发起方
Taizhou Hospital
申办方类型
Other

研究点 (1)

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