Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- thickness of scar
研究概览
简要总结
This study was designed to evaluate the scar characteristics following scheduled and emergency cesarean deliveries.
详细描述
design and settings: This study is a descriptive, cross-sectional and multicenter study conducted at Tanta and Benha Universities, Egypt in the period from August, 1, 2018 to December, 31, 2018.
Patients:
Eligibility: Nine hundred patients were selected carefully according to inclusion and exclusion criteria. The inclusion criteria were: (i) Primipara having prior cesarean delivery whether scheduled or emergency (ii) Term delivery ≥ 37 weeks of gestation (iii) Multipara having the last delivery by cesarean either scheduled or emergency (iv) The interval following cesarean delivery to be 6 months at least and (v) Double-layer repair of uterus and (vi) Cesarean by pfannensteil incisions. The exclusion criteria were: (i) Repeat cesarean sections (ii) Preterm delivery (iii) Associated placental abnormalities (iv) Single-layer repair of uterus and (v) Refusal to participate.
Allocations: This study is not a clinical trial so allocation is made based on characteristics of patients and eligibility to be allocated in either scheduled cesarean group or emergency cesarean group. The allocation was not equal based on the percentage of patients in either group. The scheduled cesarean group included 580 cases while the emergency cesarean group included 320 cases from both universities.
Intervention: Cesarean scar assessment included both uterine scar and cutaneous scar. The uterine scar was assessed by transvaginal 3D ultrasound. The used device in both universities was DC-30 device of Mindray Company. All ultrasound examinations were conducted by third author in this study. Cutaneous scar was assessed by surgery department represented by the fourth author in this study. The uterine scar in both groups was examined for distance from internal os, length, thickness, volume, vasculature and presence of any defects. Cutaneous scar was examined for distance from symphysis pubis, length, shape, any depressed areas, any defects (hernia orifice), sinus and presence of keloid or hypertrophic scar.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Primipara delivered by cs
- •Multipara with last delivery by cs
- •Full term delivery >37 weeks
- •Double layer cesarean repair
- •Pfannenstiel incison
排除标准
- •Repeat cs
- •Any placental abnormalities
- •Preterm delivery
- •Single layer cesarean repair
- •Refusal to participate
结局指标
主要结局
thickness of scar
时间窗: 6 months
Scar depth in mm
Scar vascularity
时间窗: 6 month
Doppler on scar to assess vascularity
Scar length
时间窗: 6 months
length of scar in mm
Scar characteristics
时间窗: 6 months
Site of scar in relation to internal os of cervix
Scar volume
时间窗: 6 months
Length multiplied by width multiplied by depth
次要结局
- Scar defect or niche(6 months)
研究者
Ayman S Dawood, MD
Prinicipal investigator
Tanta University
