Hyaluronic Acid and Uterine Synechiae

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention

Conditions
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Uterine Synechiae After Scraping for Natural Miscarriage

Intervention / Treatment
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* Drug: Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women patients aged between 18 and 46 years old 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: Infected miscarriage 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gel +<br>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. | Drug: Gel<br>* 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.<br>|
| No Intervention: Gel -<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine synechiae Scraping surgery Natural miscarriage