Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
364 participants
INTERVENTIONAL
2014-11-14
2018-09-14
Brief Summary
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Post-scraping uterine synechiae rate will be established at the diagnostical hysteroscopy 6-8 weeks after surgery.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Gel +
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.
Gel
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.
Gel -
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.
No interventions assigned to this group
Interventions
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Gel
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.
Eligibility Criteria
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Inclusion Criteria
* Term ≥ 7 weeks amenorrhea and ≤ 14 weeks amenorrhea
* Blighted ovum or not completed miscarriage or haemorrhagic miscarriage or retention miscarriage
* Consent signature
* Social security coverage
* Women who wants to be pregnant
Exclusion Criteria
* Uncertain diagnosis between miscarriage and extra-uterine pregnancy
* Hydatiform mole
* Uterine synechiae history
* Surgical zone infection
* Hyalobarrier® gel Endo hypersensitivity
* Clotting disorder
* Unstable diabetes
* Maternal malignant diseases
* Psychiatric disorder
* Incapacity in understanding the consent form and the questionnaires
* Law protected adult person
18 Years
46 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jean-Louis Benifla, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique
Locations
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Hôpital Lariboisière - Service de Gynécologie-Obstétrique
Paris, , France
Countries
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References
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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.
Other Identifiers
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AOR13019
Identifier Type: OTHER
Identifier Source: secondary_id
P 130911
Identifier Type: -
Identifier Source: org_study_id
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