跳至主要内容
临床试验/NCT06105034
NCT06105034已完成不适用

Placenta Accreta Spectrum Disorder Conservative Managment Versus Hysterectomy Prospective Analysis

Nourhan Elsadany1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年3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
300
试验地点
1
主要终点
Number of the patient who diagnosed intraoperative with placenta accreta spectrum disorder and undergoing conservative management or hysterectomy

研究概览

简要总结

The aim of this study is to identify risk factors associated with performing cesarean hysterectomy versus conservative management in patients with placenta accreta spectrum (PAS).

Research question What are the risk factors associated with cesarean hysterectomy in patients with placenta accreta spectrum? Research hypothesis There are certain risk factors associated with cesarean hysterectomy in patients with Placenta accreta spectrum (PAS).

详细描述

Placenta accreta spectrum disorder (PAS) is a serious obstetric disorder that is characterized by low lying and deep penetration of the villi which are abnormally attached to the myometrium of the uterus. This obstructs its complete separation during the third stage of labor which induces continued bleeding, and have potentially life- threatening for the mother. Most commonly, it is a consequence of a partial or complete absence of the compact and spongy layer known as the decidua basalis, and mis-development of the fibrinoid Nitabuch's layer which lies between the boundary zone of the thick endometrium and the cytotrophoblastic shell in the placenta.

Traditionally, caesarean hysterectomy at the time of delivery has been the preferred management strategy for placenta previa accreta. Not only does this approach preclude future fertility, but it is also a procedure synonymous with significant perioperative risks. For women who wish to conserve their reproductive function, other treatment options have been described.

1.INTRODUCTION/ REVIEW Placenta accreta is defined as "the abnormal localization and adherence of the placenta villi to the uterine myometrium. Patients at risk for abnormal placentation should be assessed antenally by ultrasonography, with or without adjunct magnetic resonance imaging if indicated . Various grading systems of villous invasion during placenta implantation are integrated to a spectrum (PAS), including placenta accreta (the villi invade superficially into the myometrium), increta (the villi invade deeper into the myometrium but do not reach the serosa), and percreta (the villi invade into the uterine serosa or adjacent organs) Clinically, severe complications of PA include severe obstetric hemorrhage leading to disseminated intravascular coagulopathy (DIC), iatrogenic injury to the ureters, bladder, bowel, respiratory distress syndrome (RDS), acute transfusion reactions, electrolyte imbalance, and renal failure. In women with PA, the expected blood loss at delivery is 3000- 5000 mL, About 90% of patients require a blood transfusion with 40% requiring more than ten units of packed cell transfusion .

The most difficult problem to deal with is controlling hemorrhage during delivery caused by PAS disorders. The potential for bleeding correlates with the degree to which the placenta invades the myometrium, the area of abnormal adherence involved, and the presence or absence of invasion into extrauterine tissues such as the bladder or parametrial tissues .

Different methods have been employed to manage the PA, ranging from uterine conservation, which involves leaving the placenta in situ, to conventional hysterectomy. Classical cesarean sections (C- sections) prevent the excessive bleeding by leaving the adherent placenta in situ and by adopting strategic planning with a comprehensive analysis that aids the reduction in maternal morbidity and mortality rates .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Pregnant women with history of previous cesarean section.
  • Age above 18 years.
  • Gestational age above 28 weeks.
  • Confirmed diagnosis of Placenta previa accreta spectrum disorder by U/S or MRI if needed.
  • U/S signs suggestive of placenta previa accrete (Green-top Guideline).

排除标准

  • Gestational age less than 28 weeks.
  • Age less than 18years

结局指标

主要结局

Number of the patient who diagnosed intraoperative with placenta accreta spectrum disorder and undergoing conservative management or hysterectomy

时间窗: from time of operation to diagnoses 1week

The diagnoses will be made based on intra-operative findings and/or pathologic features depending on the degree of placenta invasion (invading the myometrium or invading up to or beyond the uterine serosa). Patients with placenta accreta with complete peri-operative information will be included for further analysis.

次要结局

未报告次要终点

研究者

发起方
Nourhan Elsadany
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nourhan Elsadany

sponsor investigator

Ain Shams University

研究点 (1)

Loading locations...

相似试验

Placenta Accreta Spectrum Disorder Conservative... | 临床试验