跳至主要内容
临床试验/CTRI/2024/04/065068
CTRI/2024/04/065068尚未招募Unknown

Comparison of uterine closure techniques during caesarean section on isthmocele formation-A Randomized controlled trial

Sri manakula vinayagar medical college and hospital1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2024年4月15日最近更新:

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

发起方
Sri manakula vinayagar medical college and hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr M Pooja lakshmi

Sri manakula vinayagar medical college and hospital

研究点 (1)

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