Warming Contrast Media for Hysterosalpingography

Taizhou Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Infertility

Treatments: Procedure: warming the contrast media

Study type: Interventional

Funder types: Other

Identifiers

NCT01339338

Taizhou200935

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

warm media

Experimental group

Description:

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

Treatment:

Procedure: warming the contrast media

cold media

No Intervention group

Description:

the contrast media under room temperature without heat

Treatment:

Procedure: warming the contrast media