The aim of this study is to compare the efficacy of intrauterine application of heparin solution to the use of hyaluronic acid barrier gel for the prevention of intrauterine adhesion formation after operative hysteroscopy.
In this trial the investigators aim to evaluate and compare the effect of heparin solution to anti-adhesive hyaluronic barrier gel administration immediately after operative hysteroscopy on post-surgical complications (incidence, extent and severity of intrauterine adhesions, abnormal menstrual cycle pattern) and fertility. Patients undergoing operative hysteroscopy will be identified and invited to participate in the trial. At 4 to 8 weeks after the initial surgery, a follow-up, diagnostic hysteroscopy will be performed to identify indications for subsequent operative procedure and classify intrauterine adhesions according to extent of uterine cavity affected and type of formation found. Data on subsequent persistent irregular menstrual bleeding and pregnancy success up to 12 months following treatment will also be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
100
3 ml saline solution containing 5000 IU heparin.
2 ml biodegradable barrier gel containing sodium hyaluronate (10 mg/ml), sodium chloride (8.5 mg/ml), disodium hydrogen phosphate (0.34mg/ml), sodium dihydrogen phosphate (0.14 mg/ml) and water for injection (QS to weight).
Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria
RECRUITINGNadezhda Women's Health Hospital
Sofia, Bulgaria
RECRUITINGNumber of patients with post-operative intrauterine adhesion formation
Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia
Time frame: 4 to 8 weeks post treatment
Number of patients with need for subsequent operative hysterectomy
Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery
Time frame: 4 tot 8 weeks post treatment
Number of patients with persistent irregular menstrual bleeding
Recurring abnormal menstrual cycle patterns identified post initial surgery
Time frame: up to 12 months post treatment
Number of patients with fertility improvement
Successful pregnancy post surgical procedure
Time frame: up to 12 months post treatment
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