Single Layer With Unlocked Sutures Versus Double Layer Closure of Cesarean Incision and the Risk of Niche Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 1
- 主要终点
- Assessment of the presence of niche
研究概览
简要总结
This study aimed to compare the development of the uterine niche after single and double closure of cesarean incision.
详细描述
One of the most performed major surgeries worldwide is a cesarean section (CS), and CS rates are rising. These long-term complications are associated with an anatomical defect of the myometrium due to impaired healing of the incision in the uterus, a so-called uterine niche or cesarean scar defect, and with this increased rate of cesarean delivary the development of uterine niche has also increased In 50-70% of patients after cesarean section.
The classification of niche was based on the measurement of the depth, base of the isthmocele and on calculation of its triangular area. This allowed to classify the uterine niches after cesarean section according to the size of its area.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Women who undergo first elective cesarean section (CS).
排除标准
- •Women with a previous CS
- •Inadequate possibility for counselling (e.g. indication for CS without being informed about the study previously, women in severe pain without adequate therapy
- •previous major uterine surgery (e.g. laparoscopic or laparotomy fibroid resection, septum resection), Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro salpinx, uterine anomaly
- •Placenta increta or percreta during the current pregnancy
- •≥ Three foetuses during the current pregnancy.
- •Placenta previa
研究组 & 干预措施
Group I
Patients underwent uterine scar closure by single layer unlocked sutures.
干预措施: Single layer unlocked sutures (Procedure)
Group II
Patients underwent uterine scar closure by double layer unlocked sutures.
干预措施: Double layer unlocked sutures (Procedure)
结局指标
主要结局
Assessment of the presence of niche
时间窗: 6 months after the procedure
Patient were asked about any symptoms of the niche like post menstrual spotting as brownish discharge for more than two days at the end of menses or spotting more than seven days or inter menstrual blood loss that start after the end of menses or dysmenorrhea and prolonged bleeding
次要结局
未报告次要终点
研究者
Aml Abdelfatah Mohamed Ali
Resident of Obstetrics and Gynecology Department, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.
Kafrelsheikh University