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| ID | Type | Description | Link |
|---|---|---|---|
| AOR13019 | Other Identifier | Assistance Publique |
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The primary purpose of the study is to compare efficiency of a non-stick gel application after scraping surgery for natural miscarriage with no non-stick gel application after scraping surgery.
Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.
Women patients coming for natural miscarriage will be compared according to whether a non-stick gel will be applicated or not after scraping surgery.
6-8 weeks after this surgery uterine synechiae rate will be established at a diagnostical hysteroscopy. Proofreading of this exam will be made by 2 experts at the end of the study without knowing the randomization arm.
Long-term follow-up of the patients will be performed to evaluate the effect of the non-stick gel application on post-surgical fertility at 6, 12, and 24 months after scraping surgery using questionnaire asked by post, mail or phone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gel + | Experimental | Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery. |
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| Gel - | No Intervention | Patients aged of more than 18 years-old coming for a natural miscarriage who will not have the non-stick gel application at the end of the scraping surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gel | Drug | Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy. | Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery. | 6-8 weeks after scraping surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery. | Evaluation using questionnaires asked by post, mail or phone at 6, 12, and 24 months after scraping surgery. | 6, 12 and 24 months after scraping surgery |
| Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis Benifla, MD-PhD | Assistance Publique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Lariboisière - Service de Gynécologie-Obstétrique | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35667420 | Derived | Sroussi J, Bourret A, Pourcelot AG, Thubert T, Lesavre M, Legendre G, Tuffet S, Rousseau A, Benifla JL; HYFACO group. Does hyaluronic acid gel reduce intrauterine adhesions after dilation and curettage in women with miscarriage? A Multicentric randomized controlled trial (HYFACO Study). Am J Obstet Gynecol. 2022 Oct;227(4):597.e1-597.e8. doi: 10.1016/j.ajog.2022.05.064. Epub 2022 Jun 3. |
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| ID | Term |
|---|---|
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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Evaluation using questionnaires asked by post, mail or phone at 12 and 24 months after scraping surgery. |
| Evaluation of the obstetric complication rate 12 and 24 months after scraping surgery. |
| Evaluation of post-surgical synechiae stretch and severity | Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS). | 6-8 weeks after scraping surgery |
| Consistency assessment between synechiae evaluation performed at the diagnostical hysteroscopy and the synechiae evaluation performed by the 2 experts at the end of the study | Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS). | 36 months |