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临床试验/NCT04161521
NCT04161521已完成不适用

Conservative Surgical Novel Technique of Placenta Accreta in Menoufia University Hospital

Menoufia Obstetrics and Gynecology Group4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
4
主要终点
Outcome variables: Need for conversion to hysterectomy.

研究概览

简要总结

Evaluation of maternal morbidity and mortality of our novel surgical procedure for conservative management of placenta accreta in our tertiary referral institute.

详细描述

A descripative cohort study which included 60 pregnant women recuirted from Obstetrics and Gynecology Department, Menoufia University Hospital and diagnosed as placenta previa accreta.

• Ethical considerations: Ethics: The study was approved by Ethical Committee of Menoufia Faculty of Medicine.

Consent: after explanation of surgical procedure of the study, an informed written consent was obtained from all cases included in this study.

Sample size: (No= 60) Based on previous studies regarding MAP, The incidence of placenta accreta = 1/2500 , so the calculated sample size for this study was 59 which to be around 60 with confidence level 95% margin of error 5% (Pliskow S et al., 2009).

Inclusion criteria:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 1- Age between 20 - 40 years old. 2- Gestational age between 28 - 38 weeks. 3- Any patient diagnosed as placenta previa with ultrasound criteria of accretion.
  • Criteria of accretion by Colour Doppler ultrasound include: (Berkley et al., 2013).
  • The presence of irregular shaped placental lacunae within the placenta.
  • Thinning of myometrium overlying the placenta.
  • Absence of retroplacental 'non-lucent line'.
  • Protrusion of the placenta into the bladder.
  • Increased vascularity of the uterine serosa-bladder interface.
  • Turbulent blood flow through the lacunae on Doppler ultrasonography.

排除标准

  • 未提供

结局指标

主要结局

Outcome variables: Need for conversion to hysterectomy.

时间窗: 30- 90 minutes

control of bleeding and need for removal of uterus.

Blood Loss.

时间窗: During operation and 24 hours postpartum.

Amount of blood loss ,Number of packed red blood cells and blood products transfusion.

次要结局

  • Intraoperative complications(During operation and postpartum period.)

研究者

发起方
Menoufia Obstetrics and Gynecology Group
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Hamed Ellakwa

Professor Hamed Ellakwa

Menoufia Obstetrics and Gynecology Group

研究点 (4)

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