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| Name | Class |
|---|---|
| Bilar Medikal, Turkey | UNKNOWN |
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This prospective, randomized, controlled study evaluates the efficacy of self-crosslinked hyaluronic acid gel to prevent the development of de-novo intrauterine adhesions following curettage for retained product after second trimester abortion. One group of participants will underwent curettage plus intrauterine application of self-crosslinked hyaluronic acid gel while the other group will underwent curettage alone (control group).
Intrauterine adhesions are the major long-term complication of curettage for retained products of conception. The risk of adhesion is higher after second trimester abortion. This complication may result in infertility, recurrent miscarriages and irregular periods with dysmenorrhea and pelvic pain.
They have been reported that the intrauterine application of auto-crosslinked hyaluronic acid gel following hysteroscopic adhesiolysis or hysteroscopic surgery significantly reduces the formation of post-operative intrauterine adhesions.
The aim of this prospective, randomized, controlled study is to evaluate the efficacy of self-crosslinked hyaluronic acid gel in the reduction of development of de-novo post-curettage adhesions at 2 months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | The patients who are having curettage for retained product after second trimester abortion will also receive an intervention of intrauterine self-cross-linked hyaluronic acid gel after the procedure |
|
| Group 2 | No Intervention | The patients who are having curettage for retained product after second trimester abortion will receive no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrauterine self-cross-linked hyaluronic acid gel | Device | intrauterine self-cross-linked hyaluronic acid gel will apply after curettage for retained product after second trimester abortion |
| Measure | Description | Time Frame |
|---|---|---|
| The presence of de-novo post-curettage adhesions | In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| The characteristic of the intrauterine adhesions | If any intrauterine adhesion is detected during the Hysteroscopy, American Fertility Society/American Society for Reproductive Medicine classification of intrauterine adhesions will be used to describe to the characteristic of the intrauterine adhesions | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sultan Can, M.D. | Contact | +90 212 4142000 | 31687 | sltncn89@gmail.com |
| Gamze Yilmaz, M.D. | Contact | +90 212 4142000 | gmzylmz89@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ozlem Dural, M.D. | Istanbul University School Of Medicine, Department of Obstetrics and Gynecology | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24082042 | Result | Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29. | |
| 15105384 |
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| ID | Term |
|---|---|
| D018457 | Placenta, Retained |
| D014591 | Uterine Diseases |
| ID | Term |
|---|---|
| D010922 | Placenta Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22. |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D000091662 | Genital Diseases |