Is Isthmosel Becoming History? The Effect of Three Different Uterotomy Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Isthmocele was be evaluated
研究概览
简要总结
In this study, uterotomy after cesarean section was performed using 3 different suture techniques and aimed to demonstrate the potential of the baseball suture technique to prevent the isthmusel complication known as cesarean scar defect.
详细描述
An isthmocoele or cesarean scar defect is a pit-like defect in the myometrium at the isthmic level, thought to be the result of inadequate healing of the uterine incision after cesarean section. It is important not to underestimate isthmocele and to take preventive measures as it can lead to serious gynecologic and obstetric complications. However, which suturing technique is best in preventing isthmocele formation has not yet been established. The aim of this study was to compare the effects of 3 different uterine closure techniques on isthmocele formation during cesarean section.
In this study, a total of 120 term (>37 weeks) pregnant women with no previous cesarean section and scheduled for primary cesarean section will be randomized preoperatively to 3 different uterotomy closure techniques (baseball, single-lock and non-single-lock groups).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women undergoing C/S for the first time
- •37 weeks < gestation (term pregnancies)
排除标准
- •Presence of regular contractions in the uterus
- •Cervical dilatation of more than 4 cm, indicating the onset of the active phase of labour
- •Placental abnormalities
- •Previous uterine surgery
- •Multiple pregnancy
- •Premature rupture of membranes
- •Chorioamnionitis
- •Preoperative haemoglobin level below 10g/dl
- •Body mass index (BMI) above 35kg/m2
- •Any comorbidity (e.g. diabetes, hypertension, pre-eclampsia, eclampsia)
- •Smoking and/or alcohol use
- •The need for a blood transfusion.
研究组 & 干预措施
Isthmosel (caesarean scar defect )
Isthmosel or caesarean scar defect is a poch-like defect in the myometrium at the isthmic level that is thought that it might occur as a result of insufficient healing process of the uterine incision after caesarean section.
干预措施: Baseball Suturing Technique (Procedure)
Isthmosel (caesarean scar defect )
Isthmosel or caesarean scar defect is a poch-like defect in the myometrium at the isthmic level that is thought that it might occur as a result of insufficient healing process of the uterine incision after caesarean section.
干预措施: Single-Layer Locked Continuous Suturing Technique (Procedure)
Isthmosel (caesarean scar defect )
Isthmosel or caesarean scar defect is a poch-like defect in the myometrium at the isthmic level that is thought that it might occur as a result of insufficient healing process of the uterine incision after caesarean section.
干预措施: Single-Layer Unlocked Continuous Suturing Technique (Procedure)
Residual myometrial thickness
Three months after the operation, residual myometrial thickness localization was evaluated by ultrasonography.
干预措施: Baseball Suturing Technique (Procedure)
Residual myometrial thickness
Three months after the operation, residual myometrial thickness localization was evaluated by ultrasonography.
干预措施: Single-Layer Locked Continuous Suturing Technique (Procedure)
Residual myometrial thickness
Three months after the operation, residual myometrial thickness localization was evaluated by ultrasonography.
干预措施: Single-Layer Unlocked Continuous Suturing Technique (Procedure)
结局指标
主要结局
Isthmocele was be evaluated
时间窗: Three months postoperatively
The presence and anatomical location of isthmocele were be evaluated by ultrasonography.
次要结局
未报告次要终点