Comparison of uterine closure techniques during caesarean section on isthmocele formation-A Randomized controlled trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- To compare the uterine closure techniques on isthmocele formation in primary and repeat caesarean section
研究概览
简要总结
Caesarean section is increasing worldwide. Current caesarean section rate is 15-20%. As a result of caesarean section, there are chances for suture site weakening. Medical terminology for weakness of scar, resulting in bulge in lower uterus is called as isthmocele or niche. Isthmocele results in menstrual abnormality in inter-delivery period. During pregnancy, it can result in scar thinning out during delivery. Usually uterine closure is done with either single layer or double layer closure technique, single layer uterine closure technique results in slightly higher chance of weakening of scar compared to double layer. Within double layer closure there are different techniques. We aim to compare 3 different double layered suturing methods [ double layer locking versus double layer unlocking versus Babu and Magon technique (Far Far Near Near technique)] and check technique results in thick scar without isthmocele formation. Following 6-12 months of caesarean section, we perform a vaginal scan to check the whether the scar is healed well or there is formation of isthmocele. In this way of research, we are trying to find out the effective method of suturing technique to reduce chances of rupture uterus in next pregnancy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •singleton pregnancies undergoing elective and emergency caesarean delivery.
排除标准
- •1.Preterm caesarean section 2.Placenta previa 3.History of scar dehiscence in patients who have undergone caesarean section before.
结局指标
主要结局
To compare the uterine closure techniques on isthmocele formation in primary and repeat caesarean section
时间窗: After 6-12 months of caesarean section
(Niche length
时间窗: After 6-12 months of caesarean section
Niche depth
时间窗: After 6-12 months of caesarean section
Residual myometrial thickness Adjacent myometrial thickness)
时间窗: After 6-12 months of caesarean section
次要结局
- To compare the effect of different uterine closure techniques on residual myometrial thickness in primary & repeat caesarean section(Residual myometrial thickness)(To compare the need for additional sutures required between different uterine closure techniques)
研究者
Dr M Pooja lakshmi
Sri manakula vinayagar medical college and hospital
