A Randomized Clinical Study Based on Comparison Between Closure of Uterine Incision With Vicryl 2/0 Versus Vicryl 1 in Development of Uterine Niche.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- prevalence of uterine niche
研究概览
简要总结
The first group patients underwent double layer closure with split thickness with vicryl 2/0, in continuous, non- locked, 1 cm apart sutures, study group, and the second group, women underwent double layer closure with split thickness with vicryl 1, in continuous, non- locked, 1 cm apart sutures, control group. Then, all women in the study were followed up for development of niche within 1 to 6 weeks. The assessment after one week postpartum was with using trans-abdominal Ultrasound, then after two to six weeks postpartum with transvaginal Ultrasound
详细描述
Caesarean section rates have increased worldwide over the past decades from 6.7 to 19.1%, with a current European CS rate of 25% of all births. CS is considered to be a safe procedure that can be life saving for both mother and child but the increasing trend draws more attention to adverse outcomes related to CSs. A relatively new long-term sequela is the niche in the uterine caesarean scar. A niche is defined as "an indentation at the site of the uterine caesarean scar with a depth of at least 2 mm on ultrasound" and is present in 56-84% of women after one or more CSs .
It is realized that almost all of the increase in cesarean section rate is due to the increase in repeat operations, and primary cesarean deliveries for dystocia and fetal distress. These can be attributed to obstetric factors as increased primary cesarean delivery rate, failed induction. Maternal factors as Increased proportion of women > age 35, increased nulliparous women, increased elective primary cesarean deliveries and factors relating to the physician as Malpractice litigation concerns .
The hypotheses can be divided into surgery-related factors and patient related factors. In their paper they focused on surgery-related factors since these could be easily modified and studied in future RCTs .
These surgical-related factors include low (cervical) location of the uterine incision during a CS, Incomplete closure of the uterine wall, due to single-layer, endometrial saving closure technique or use of locking sutures and Surgical activities that may induce adhesion formation (i.e., non-closure of peritoneum, inadequate hemostasis, applied sutures, use of adhesion barriers).
Without questions, the uterine niche presents a pathology that requires evaluation and intervention to mitigate its prevalence. The aim of this study is to compare between closures of uterine incision with Vicryl 2/0 versus Vicryl 1 in developing a uterine niche.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton term pregnancy.
- •Parity less than
- •Women who undergo 1st cesarean section whether in labor or not.
排除标准
- •Women with a previous CS.
- •Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection).
- •Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro-salpinx, uterine anomaly or endocrine disorders disturbing ovulation).
- •Abnormally invasive placenta during the current pregnancy.
- •Multiple gestation, polyhydramnios.
- •Maternal Diabetes, anemia and connective tissue disorders.
- •Women with Body mass index >
- •Women with valval varicosities.
结局指标
主要结局
prevalence of uterine niche
时间窗: 6 weeks
using transvaginal ultrasound for detection of development of CS scar niche
次要结局
- operative blood loss(2 hours)
- postoperative haemoglobin(24 hours)
- operative time(1 hour)
- size of cs niche(6 weeks)
研究者
Bassiony Dabian
lecturer of obstetrics and gynecology
Cairo University