Intrauterine Adhesion
Conditions
Keywords
operative hysteroscopy, heparin, anti-adhesion barrier gel, intrauterine adhesion, hyaluronic acid
Brief summary
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
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.
Interventions
DRUGHeparin solution
3 ml saline solution containing 5000 IU heparin.
DRUGAnti-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).
Sponsors
Nadezhda Women's Health Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients will be under general anaesthesia during surgical procedure when the allocated treatment will be administered.
Intervention model description
Comparison between two active intrauterine treatments administered immediately post surgery
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with post-operative intrauterine adhesion formation | 4 to 8 weeks post treatment | Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia |
| Number of patients with need for subsequent operative hysterectomy | 4 tot 8 weeks post treatment | Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery |
| Number of patients with persistent irregular menstrual bleeding | up to 12 months post treatment | Recurring abnormal menstrual cycle patterns identified post initial surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with fertility improvement | up to 12 months post treatment | Successful pregnancy post surgical procedure |
Countries
Bulgaria
Contacts
Primary ContactGeorgi Stamenov
Outcome results
None listed