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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin solution | Active Comparator | Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy. |
|
| Anti-adhesion barrier gel | Active Comparator | Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin solution | Drug | 3 ml saline solution containing 5000 IU heparin. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with fertility improvement | Successful pregnancy post surgical procedure | up to 12 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Georgi Stamenov | Contact | +359888269839 | g.stamenov1@abv.bg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nadezhda Women's Health Hospital | Recruiting | Sofia | Sofia | 1330 | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27173082 | Background | Healy MW, Schexnayder B, Connell MT, Terry N, DeCherney AH, Csokmay JM, Yauger BJ, Hill MJ. Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis. Am J Obstet Gynecol. 2016 Sep;215(3):267-275.e7. doi: 10.1016/j.ajog.2016.05.001. Epub 2016 May 10. | |
| 3381869 | Background | Valle RF, Sciarra JJ. Intrauterine adhesions: hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1459-70. doi: 10.1016/0002-9378(88)90382-1. |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Comparison between two active intrauterine treatments administered immediately post surgery
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Patients will be under general anaesthesia during surgical procedure when the allocated treatment will be administered.
| Anti-adhesion barrier gel | Drug | 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 | Recruiting | Sofia | 1373 | Bulgaria |
|
| 17452399 | Background | Nappi C, Di Spiezio Sardo A, Greco E, Guida M, Bettocchi S, Bifulco G. Prevention of adhesions in gynaecological endoscopy. Hum Reprod Update. 2007 Jul-Aug;13(4):379-94. doi: 10.1093/humupd/dml061. Epub 2007 Apr 23. |
| 33623830 | Background | van Wessel S, Hamerlynck T, Schutyser V, Tomassetti C, Wyns C, Nisolle M, Verguts J, Colman R, Weyers S, Bosteels J. Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol. Hum Reprod Open. 2021 Feb 16;2021(1):hoab001. doi: 10.1093/hropen/hoab001. eCollection 2021. |
| 34068335 | Background | Lee WL, Liu CH, Cheng M, Chang WH, Liu WM, Wang PH. Focus on the Primary Prevention of Intrauterine Adhesions: Current Concept and Vision. Int J Mol Sci. 2021 May 13;22(10):5175. doi: 10.3390/ijms22105175. |
| D000091662 | Genital Diseases |