Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intrauterine Adhesions Prevention: the Use of Heparin Solution Compared to Application of Anti-adhesion Barrier Gel After Operative Hysteroscopy

Conditions
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Intrauterine Adhesion

Intervention / Treatment
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* Drug: Heparin solution
* Drug: Anti-adhesion barrier gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female sex indication for operative hysteroscopy including one or more of the following: infertility, irregular bleeding, oligo-/amenorrhea, Asherman syndrome, G0-G3 fibroids, dysmorphic uterus. Exclusion Criteria: ongoing pregnancy, genital cancer, pelvic inflammatory disease, excessive uterine bleeding.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison between two active intrauterine treatments administered immediately post surgery
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Heparin solution<br>Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy. | Drug: Heparin solution<br>* 3 ml saline solution containing 5000 IU heparin.<br>|
| Active Comparator: Anti-adhesion barrier gel<br>Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy. | Drug: Anti-adhesion barrier gel<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number 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 | 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 | 4 tot 8 weeks post treatment | 
| Number of patients with persistent irregular menstrual bleeding | Recurring abnormal menstrual cycle patterns identified post initial surgery | up to 12 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with fertility improvement | Successful pregnancy post surgical procedure | up to 12 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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operative hysteroscopy, heparin, anti-adhesion barrier gel, intrauterine adhesion, hyaluronic acid