Warming Contrast Media for Hysterosalpingography

Phase 1

• Conditions: Infertility
• Interventions: Procedure: warming the contrast media

• Registration Number: NCT01339338
• Lead Sponsor: Taizhou Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2011-04
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-19
• Last Update Submitted: 2011-04-19
• Study First Posted: 2011-04-20
• Last Update Posted: 2011-04-20
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• infertile women who seeking for HSG testing

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
warm media	warming the contrast media	Subjects undergo HSG using a warm media heated with a 37℃ water-bathing
cold media	warming the contrast media	the contrast media under room temperature without heat

Primary Outcome Measures

Name	Time	Method
incidence of vasovagal episodes	from the injection of the media to a half hour after HSG	vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale pain score during HSG	within the first 30 seconds after the constra media "spill out"	assessing the average pain score during HSG,Immediately after the constra media "spill out" the tubal fimbria and spread into periotneum.
Visual analogue scale pain score after HSG	a half hour after HSG	10cm Visual analogue scale pain score after HSG

Trial Locations

Locations (1)

Taizhou Hospital of zhejiang Province; 🇨🇳 Taizhou City, Zhejiang, China