Sparse Uterine Closure in Caesarean Section: Short and Mid Term Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- uterine scar quality
研究概览
简要总结
The existence and the characteristics of a wedge- shaped defect in the uterine incision scar were demonstrated by radiologic, ultrasonographic, endoscopic and histologic methods by various authors.
Cesarean scar defect is a deficient uterine scar or scar dehiscence following a cesarean section involving myometrial discontinuity at the site of a previous cesarean section scar. Cesarean scar defects may be associated with many clinical problems such as ectopicpregnancy at the cesarean section scar, rupture of the uterus during a subsequent pregnancy, dysmenorrhea and abnormal uterine bleeding during the non-pregnant state. These complications are likely to be associated with poor uterine scar healing following cesarean sections.
Methods concerning closure of the uterine incision need to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing cesarean section.
Sur-gical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity.
For this reason, investigators designed this prospective clinical study to analyze the effects of two different uterine suturing techniques. their aim was to compare the sparse closure of the uterine incision to classical one layer closure regarding short , mid and long term results. In deed, they compared :
- duration of surgery and calculated blood loss during surgery as short term results - incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
- Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy of these patients as long-term results.
详细描述
This is a secondary analyse of a first randomised trial comparing two caesarean techniques :
- Misgav Ladach with a one layer classic uterine closure.
- French ambulatory Caesarean section with a sparse uterine closure . The first trial is registred under the reference number : NCT03741907. 100 patients with an indication of an elective caesarean section were included in this trial : 50 had a one layer classic uterine closure and are enrolled in groupe 1 and 50 had a sparse uterine closure and are enrolled in groupe 2 .
- For the short term results investigators compared : duration of uterine sutures , visually estimated and calculated blood loss
- For the mid term results investigators are shuduling for all partient an hysterosonography 6 mounths after surgery and then will compare : incidence of postoperative defective healing of the uterine incision , thickness of the ultrasound imaged uterine scar as mid-term results .
- For the long term results investigators will interview patients 2 years after surgery in order to check for Incomplete uterine rupture, morbidly placental adhesion during subsequent pregnancy .
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnancy
- •Cicatricial uterus with contraindication to vaginal delivery (uterus bi or multi-cicatricial, corporal uterine scar, intra-mural myomectomy, dystocic presentation)
- •Fetal macrosomia with a weight greater than 4Kg
- •Placenta previa
排除标准
- •Patients who refuse to participate in the study
- •prenatally diagnosed fetal pathology (intrauterine growth restriction, malformation, genetics disorders)
- •adherent placenta, an adnexal mass or a myoma at the lower uterine segment
- •Cesarean section in a context of medical or obstetrical emergency
- •Caesarean section with a high risk of bleeding
结局指标
主要结局
uterine scar quality
时间窗: 6 mounth after surgery
ultrasound visualization of a defect on the internal wall of the uterine scar (niche)
次要结局
- calculated blood loss(before and 24 hours after surgery)
- uterine scar thickness(6 mounth after surgery)
- duration of surgery(during the caesarean section)
研究者
Kaouther Dimassi
associate professor in obstetrics and gynecology
University Tunis El Manar