Uterine Synechiae After Scraping for Natural Miscarriage
Conditions
Keywords
Uterine synechiae Scraping surgery Natural miscarriage
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.
Interventions
DRUGGel
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 46 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
France
Outcome results
None listed