NCT02318212已完成不适用
International Observational E-Registry on the Use of Dilapan-S/Dilasoft Osmotic Dilators for Cervical Priming Prior to Induced Abortion
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 主要终点
- Number of inserted osmotic dilators
研究概览
简要总结
International Observational E-Registry on the use of osmotic dilators DILAPAN-S® / DILASOFT® for cervical priming prior to induced abortion.
详细描述
International, multicentre, non-interventional, observational e-registry, post market clinical follow up study to document current clinical use of Dilapan-S or Dilasoft for cervical priming before induced abortion with regard to the number of dilators used, duration of insertion of dilators in situ and unusual complications consequent of their use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Intrauterine pregnancy ≥ 6 and ≤ 24 weeks gestation
- •Patients who are capable of giving consent and sign the form
- •Abortion being made in compliance with the Abortion Act 1967 (For England, Wales and Scotland)
排除标准
- •Clinical signs of uterine, vaginal or vulvar infection
- •Acute bleeding
结局指标
主要结局
Number of inserted osmotic dilators
时间窗: max. up to 24 hrs; estimated average 6 hrs
Total time taken for cervical priming with Dilapan-S/Dilasoft
时间窗: max. up to 24 hrs; estimated average 6 hrs
Duration of leaving osmotic dilators in situ
次要结局
- Type of synthetic osmotic dilator used(max. up to 24 hrs; estimated average 6 hrs)
- Complications during cervical priming(up to 24 hrs; estimated average 6 hrs)
- Other observed undesirable effects uf use of synthetic osmotic dilators(up to 24 hrs; estimated average 6 hrs)
- Need of additional mechanical dilation(up to 10 minutes after osmotic dilators extraction)
- Surgical operative time(estimated max. up to 10 min, estimated average 8 min.)
- Initiation-to-delivery time(hrs)
- Induction-to-delivery time(up to 72 hrs; estimated average 48 hrs)
- Complications related to induced abortion procedure(up to 24 hrs; estimated average 12 hrs)
- Infectious complication and its relation to the use of Dilapan-S/Dilasoft(up to 72 hrs; Complications, if any, will be followed-up until stable situation has been reached.)
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