Non-stick Gel Applicated After Scraping Surgery for Natural Miscarriage and Uterine Synechiae Prevention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Gel (Drug)
结局指标
主要结局
Evaluation of post-surgical uterine synechiae rate during a diagnostical hysteroscopy.
时间窗: 6-8 weeks after scraping surgery
Diagnostical hysteroscopy performed 6-8 weeks after scraping surgery.
次要结局
- 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 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 of post-surgical synechiae stretch and severity(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(36 months)