Warming Contrast Media for Hysterosalpingography
Recruitment status was Recruiting
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Purpose
The purpose of this study is to compare the use of warm-media with cold-media in performing hysterosalpingography (HSG).
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Procedure: warming the contrast media |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Comparison of the Warm and Cold Contrast Media for Hysterosalpingography: a Prospective, Randomized Study |
- incidence of vasovagal episodes [ Time Frame: from the injection of the media to a half hour after HSG ] [ Designated as safety issue: Yes ]vasovagal episodes include nausea, Vomit, Sweating, Weakness and bradycardia occurred in HSG
- Visual analogue scale pain score during HSG [ Time Frame: within the first 30 seconds after the constra media "spill out" ] [ Designated as safety issue: No ]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 [ Time Frame: a half hour after HSG ] [ Designated as safety issue: No ]10cm Visual analogue scale pain score after HSG
| Estimated Enrollment: | 300 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: warm media
Subjects undergo HSG using a warm media heated with a 37℃ water-bathing
|
Procedure: warming the contrast media
warm the contrast media with 37℃ water-bathing
Other Name: warm media
|
|
No Intervention: cold media
the contrast media under room temperature without heat
|
Procedure: warming the contrast media
warm the contrast media with 37℃ water-bathing
Other Name: warm media
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Yi-Yang Zhu, MD | 86-057-6519-1400 | yiangz@sohu.com |
| China, Zhejiang | |
| Taizhou Hospital of zhejiang Province | Recruiting |
| Taizhou City, Zhejiang, China, 317000 | |
| Contact: YiYang Zhu, MD 86-057-6519-1400 yiangz@sohu.com | |
| Principal Investigator: Xianhua Lin | |
| Principal Investigator: YingZi Mao | |
| Principal Investigator: Qunxi Cai | |
| Study Director: | YiYang Zhu, MD | Centra for Reproductive Medicine of Taizhou hospital |
More Information
No publications provided by Taizhou Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | YiYang Zhu/Centra for Reproductive Medicine, Taizhou hospital of Zhejiang Province |
| ClinicalTrials.gov Identifier: | NCT01339338 History of Changes |
| Other Study ID Numbers: | Taizhou200935 |
| Study First Received: | April 12, 2011 |
| Last Updated: | April 19, 2011 |
| Health Authority: | China: Ministry of Health |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 17, 2013