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Clinical trial

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

ID
Name
3/11022022
Description
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.
Trial arms
Trial start
2022-02-14
Estimated PCD
2026-02-14
Trial end
2026-02-28
Status
Recruiting
Treatment
Heparin solution
3 ml saline solution containing 5000 IU heparin.
Arms:
Heparin solution
Other names:
HEP
Anti-adhesion barrier gel
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).
Arms:
Anti-adhesion barrier gel
Other names:
AAB
Size
100
Primary endpoint
Number of patients with post-operative intrauterine adhesion formation
4 to 8 weeks post treatment
Number of patients with need for subsequent operative hysterectomy
4 tot 8 weeks post treatment
Number of patients with persistent irregular menstrual bleeding
up to 12 months post treatment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Comparison between two active intrauterine treatments administered immediately post surgery', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patients will be under general anaesthesia during surgical procedure when the allocated treatment will be administered.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-03-22

1 organization

2 products

1 indication

Organization
Nadezhda Women's Health Hospital
Product
Heparin
Indication
Uterine synechiae
Product
Anti-adhesion barrier gel