The Effect of Hysterotomy Technique on the Rate of Large Defects in the Hysterotomy Scar
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- large defect
研究概览
简要总结
The Effect of Cesarean Operative Technique on the Occurrence of Large Hysterotomy Scar Defects.
详细描述
Having a Caesarean leads to a scar in the uterus, which does not always heal properly. Defective healing can lead to serious complications in the next pregnancy and delivery. Different surgical techniques can be used for a Caesarean section.
The aim is to compare two surgical techniques (different ways of opening the uterus), to investigate whether one or the other technique leads to fewer defective scars in the uterus. Both these techniques are in use at the clinic. After the operation, patients are cared for in the normal way.
Six months after the Caesarean, patients are examined using vaginal ultrasound. Vaginal ultrasound allows to see if the scar after the Caesarean has healed well, or if there are defects in it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
the surgeon who performed the operation knew what technique to use. Participant were not informed in what group they were. Six months postpartum patients came to ultrasound department and underwent ultrasound examination of uterus and uterine cesarean scar. Sonographer was blinded to the surgery technique.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
high incision group
hysterotomy at cesarean performed 2 cm above plica vesicouterina
干预措施: hysterotomy at cesarean (Procedure)
low incision group
hysterotomy at cesarean performed 2 cm below plica vesicouterina
干预措施: hysterotomy at cesarean (Procedure)
结局指标
主要结局
large defect
时间窗: 6 months
occurrence of large defects in uterine cesarean scar are detected by ultrasound and are assessed by the percentage of patients who have large defects in uterine cesarean scar
次要结局
- uterina rupture/uterine dehiscence(up to 8 years)
- scar pregnancy(up to 8 years)
- difficulties at delivery of fetus(1 hour)
- readmission to the hospital(8 weeks)
- miscarriage(up to 8 years)
- placenta previa/accreta(up to 8 years)
- APGAR score(1 and 5 minute after delivery)
- blood loss(1 hour)
- postoperative infection(8 weeks)
- vaginal delivery after caesarean(up to 8 years)