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临床试验/NCT03609281
NCT03609281已完成不适用

Cesarean Scar Characteristics After Scheduled and Emergency Cesarean Deliveries: A Single Center Study

Tanta University1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2018年8月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman S Dawood, MD

Prinicipal investigator

Tanta University

研究点 (1)

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