Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants for each group for study
研究概览
简要总结
Caesarean section scar may have result as isthmocele or scar detachment during pregnancy which is in few years after previous delivery. Uterine niche is the most effectively used measurement side of uterus to estimate for these detachment complications. The aim of this study is to support this niche site by supporting the classical uterine closure technique.
详细描述
Cesarean delivery rate continues to increase in world in concern with uterine scar complications as placental invasion abnormalities, isthmocele or previous scar detachment during pregnancy (post surgical long term complications). Uterine niche is the presence of a hypoechoic area within the myometrium on the lower uterine segment, showing a defect of the myometrium at the site of a previous cesarean delivery. Some surgical techniques have been trying to support this area to prevent the post surgical long term complications. In this study the investigators have been trying to find out a new technique by applying supporting sutures during uterine closure in cesarean section. Three months after the surgery, the uterine niche measurement will be examined with ultrasonography for both study and classical groups and results will be compared between the groups.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
One study control person is organizing the whole trial and provides blinding to both sides (participants and care provider).
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
- •Primigravid elective caesarian delivery candidates
- •The participants will have not any uterine contraction or cervical dilatation before delivery.
- •Having no systemic or obstetric illnesses
- •Participants who are accept to participate in this study with their written consent.
排除标准
- •Previous caesarian delivery
- •Having uterine contraction or cervical dilatation
- •Smoking cigarettes
- •Having systemic or obstetric illnesses
研究组 & 干预措施
Study caesarean group
Care providers are applying additional sutures to standard caesarean procedure for participants.
干预措施: Suture technique (Other)
Classical caesarean group
Care providers are applying standard caesarean procedure for participants.
结局指标
主要结局
Number of participants for each group for study
时间窗: Up to 9 months
We will try to reach fifty participants for each group (study group as classical cesarean with supporting suture and control group as classical cesarean) . When we reach to all participants we will stop to enroll the participants.
次要结局
未报告次要终点
研究者
Ergul Demircivi Bor
Principal Investigator
Kanuni Sultan Suleyman Training and Research Hospital