The purpose of this study is: * to determine whether the choice of the device for performing hysterosalpingography on the basis of the cervix characteristics can reduce the procedure failure rate; * to determine whether patient medical history is correlated with the degree of pain experienced during the HSG procedure.
A group of women will be randomized to undergo HSG, using 1) a balloon catheter in a first group of patients; 2) a cervical vacuum cup in a second group; 3) one of the two devices decided by the operator depending on the cervix characteristics in a third group (that will be named "operator's choice"). The operator will ask the woman to evaluate the degree of pain experienced during the application of the device and the injection of the contrast, after 2, 6 and 24 hours. The degree of pain will be evaluated using the VAS system, an analogue scale rating from 1 to 10. A nurse will notice the patient's reaction and will evaluate the pain, depending on the movements of the hands and the body and the woman's moaning. Moreover, the assistant will note down the personal data and the history of the patient. The operator will record the objective and subjective difficulty of the performance, using a rating scale from 0 to 9. The length of the procedure, the volume of contrast used, the amount of radiations and the time of exposure of the patient will also be considered. At the end of HSG both the gynaecologist and the radiologist will express their satisfaction upon the examination with a score from 0 to 10.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
222
Hysterosalpingography is performed using intrauterine balloon catheter
Hysterosalpingography is performed using cervical vacuum cup
IRCCS Burlo Garofolo
Trieste, Italy
failure rate to complete hysterosalpingography (HSG)
Time frame: two years
the objective difficulty to perform HSG
Time frame: two years
the subjective difficulty to perform HSG
Time frame: two years
the fluoroscopic time
Time frame: two years
the length of the procedure of device application
Time frame: two years
the volume of contrast medium used
Time frame: two years
gynecologist satisfaction with the procedure
Time frame: two years
radiologist satisfaction with the procedure
Time frame: two years
the percentage of short-term complications
Time frame: two years
the percentage of long-term complications
Time frame: two years
correlation between patient medical history and the degree of pain experienced during the HSG procedure
Time frame: two years
the degree of pain experienced during the HSG procedure
Time frame: two years
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