Hyaluronic Acid and Uterine Synechiae
- Conditions
- Uterine Synechiae After Scraping for Natural Miscarriage
- Interventions
- Drug: Gel
- Registration Number
- NCT02248376
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 364
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Gel + 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.
- Primary Outcome Measures
Name Time Method Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy. 6-8 weeks after scraping surgery Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.
- Secondary Outcome Measures
Name Time Method Evaluation of the effect of the non-stick gel application on the post-surgical fertility 6, 12, and 24 months after scraping surgery. 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.
Evaluation of the obstetric complication rate 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 post-surgical synechiae stretch and severity 6-8 weeks after scraping surgery Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
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 36 months Synechiae stretch and severity will be evaluated by the American Fertility Society classification (rAFS).
Trial Locations
- Locations (1)
Hôpital Lariboisière - Service de Gynécologie-Obstétrique
🇫🇷Paris, France