Randomized Controlled Study: Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Initial cervical opening and the need for further dilatation at the start of the procedure
研究概览
简要总结
This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol.
The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria.
The investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.
详细描述
This is a prospective randomized study.
The aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol.
Primary outcome measures will include:
Initial cervical opening and the need for further dilatation at the procedure Procedure duration
Difficulty score performing the abortion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients with a viable singleton
- •Pregnancy 14-20 weeks of gestation
- •Admitted for termination of pregnancy
排除标准
- •Contraindication for administration of Misoprostol
- •Patients with more than one previous cesarean section scar
- •Patients with impaired coagulation
- •Significant pulmonary or cardiac disease
- •Non viable pregnancy
- •Placenta accreta or previa by ultrasound
研究组 & 干预措施
Laminaria group
Patients in this group will have cervical preparation with laminaria MedGyn Products, Inc. USA overnight the day before the abortion
干预措施: Laminaria, MedGyn Products, Inc. USA. (Device)
Misoprostol group
Patients in this group will have cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
干预措施: Misoprostol (Drug)
结局指标
主要结局
Initial cervical opening and the need for further dilatation at the start of the procedure
时间窗: 8-12 hours after insersion of laminaria or Misoprostol
The surgical abortion will be performed 8-12 hours after the insertion of laminaria, or after vaginal application of Misoprostol
次要结局
- pain score during cervical preparation and after the procedure(at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia)