跳至主要内容
临床试验/NCT04210479
NCT04210479Unknown不适用

Bladder Filling in Cesarean Hysterectomy for Placenta Percreta: A Randomized Trial

Hatem AbuHashim0 个研究点目标入组 64 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
64
主要终点
Rate of urinary bladder injury

研究概览

简要总结

The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates. including less blood loss, fewer transfusion requirements and, intraoperative urinary tract injury as well as improve fetal outcome.

Ultrasound evaluation is the recommended first-line modality for diagnosing PAS. Ultrasound features suggestive of PAS include loss of the normal retroplacental clear zone, attenuation of the uterine-bladder interface, reduced retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder. A systematic review reported that the antenatal diagnosis of PAS significantly lowered the rate of urinary tract injury (from 63% to 39%) during cesarean hysterectomies in these cases.

Unlike other elective cesarean hysterectomies, cesarean hysterectomy with a placenta previa increta/percreta, is more difficult. There is a greater need to both keep a margin from the vascular cervical-placental mass and simultaneously protect the urinary bladder. Case series reported that bladder filling helps the surgeon to more clearly identify the planes of dissection and secure the engorged aberrant vessels, thereby reduces bladder injury. Accordingly, a prospective randomized study in pregnant patients with placenta previa increta/percreta undergoing elective cesarean hysterectomy will be conducted to address this important issue.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women in their third trimester (35-37 W).
  • Placenta previa accreta spectrum identified by the Ultrasound (low lying anterior or major degree anterior).
  • With at least one prior cesarean section.
  • Elective cesarean hysterectomy.
  • Evidence of gross placental invasion at the time of surgery (FIGO grade 3a.

排除标准

  • Patients undergoing conservative treatment.
  • Emergency cesarean hysterectomy.
  • No evidence of gross placental invasion at the time of surgery.
  • Posterior placenta.

结局指标

主要结局

Rate of urinary bladder injury

时间窗: Intra-operative (i.e. during surgery).

Unintentional bladder injury during elective cesarean hysterectomy

次要结局

未报告次要终点

研究者

发起方
Hatem AbuHashim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hatem AbuHashim

Professor

Mansoura University

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