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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
364
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.
Hôpital Lariboisière - Service de Gynécologie-Obstétrique
Paris, France
Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.
Time frame: 6-8 weeks after scraping surgery
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 36 months
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