CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
RESEARCH SUPPORT, NON-U.S. GOV'T
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Contrast infusion sonography in the post-Essure setting.

STUDY OBJECTIVE: To compare contrast infusion sonogram (CIS) to hysterosalpingogram (HSG) for use as a 3-month confirmation test after Essure.

DESIGN: Pilot study (Canadian Task Force classification II-2).

SETTING: Healthy women in an academic multispecialty group.

PATIENTS: Seventeen women desiring permanent sterilization who had had successful bilateral Essure placement within 12 weeks.

INTERVENTION: Contrast infusion sonography was performed and immediately followed by an HSG at the same appointment, between 1 and 12 weeks after Essure placement.

MEASUREMENTS AND MAIN RESULTS: To determine how well microinsert location and tubal status can be assessed with CIS, an adaptation of hysterosalpingo contrast sonography (HyCoSy), when compared with sequential HSG. Tubal occlusion rate within 4 to 8 weeks after Essure placement was also noted. All microinserts were readily identified with ultrasound, and location was accurately determined. In all patients (100%) with at least 1 tube patent on HSG, patency was also demonstrated on CIS by visualizing real-time flow in the tube or the presence of dye in the cul-de-sac or adnexa. There were no significant adverse events, and pain ratings were similar for both tests. The majority (88%) of patients felt strongly that they would prefer to have a 3-month confirmation test performed in the gynecologist's office rather than an unfamiliar radiologic facility. Tubal occlusion was noted on both CIS and HSG in 82% of patients before 12 weeks.

CONCLUSION: Based on this pilot study with a small sample, CIS, an adaptation of HyCoSy, has comparable accuracy to HSG in the post-Essure setting. The safety, convenience, and comfort of an in-office test using ultrasound and a non-iodine-based dye would be a welcome alternative to HSG. There was also a high rate of bilateral fallopian tube occlusion noted on HSG at 4 weeks after Essure.

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