跳至主要内容
临床试验/NCT05314595
NCT05314595Unknown不适用

The Effect of Bilateral Uterine Artery Ligation as an Added Step for Placental Pouch Closure Technique in Management of Placenta Accreta Spectrum on Reducing Intra-operative Blood Loss: A Comparative Study

Assiut University2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
130
试验地点
2
主要终点
bilateral uterine artery ligation

研究概览

简要总结

Aim of the study

Primary outcomes:

  1. The effect of bilateral uterine artery ligation in reducing intraoperative bleeding in women underwent PPC as a conservative surgical technique.
  2. Decrease surgical time.

Secondary outcomes:

  1. Associated maternal morbidity and mortality.
  2. Amount of blood transfusion
  3. Difference in hematocrit value before and after delivery

详细描述

Introduction Placenta accreta spectrum (PAS) is a term that comprises abnormal placental invasion disorders of the uterine wall. According to the depth of invasion, it ranges from placental invasion in contact with myometrium (placenta accreta), into myometrium (placenta increta), or beyond myometrium (placenta percreta) (Tan, Tay et al. 2007, Cal, Ayres-de-Campos et al. 2018). PAS is an obstetric emergency that may be complicated by emergency hysterectomy, intraoperative surgical complications, massive transfusion, hemorrhagic shock, and even maternal death if not managed efficiently (Ye 2017). Previous cesarean deliveries, placenta previa and advanced maternal age are recognized strong risk factors of PAS, all of which, have become more prevalent among contemporary population (Silver, Landon et al. 2006, Zeng, Yang et al. 2018). Therefore, PAS is no longer a rare disorder in modern practice; the incidence of PAS has increased from approximately 1 in 30,000 deliveries before 1950 to 3 in 1000 deliveries in the current decade (Timor-Tritsch, Monteagudo et al. 2012).

Currently, cesarean hysterectomy is the standard management of PAS (Matsubara, Kuwata et al. 2013). Despite surgical risks, loss of uterine function, and psychological sequences, cesarean hysterectomy permits elective intervention under controlled settings to minimize blood loss (2002). Although several uterus-conserving interventions have been proposed in management of PAS, their contribution to evidence-based practice is limited (Jauniaux, Alfirevic et al. 2018), and cesarean hysterectomy is endorsed as the standard intervention (gynaecology, Gynaecology et al. 2002). Cesarean hysterectomy, without attempting to remove the placenta, may reduce risk of significant bleeding and associated morbidity (Eller, Porter et al. 2009). Leaving the placenta in situ is endorsed as an alternative in patients who refuse hysterectomy being the least invasive uterus-conserving intervention (Jauniaux, Alfirevic et al. 2018, Sentilhes, Kayem et al. 2018).

Nevertheless, the need for evidence-based conservative approaches for PAS cannot be underestimated particularly among women who are highly motivated to preserve their fertility. Despite limited evidence, an international survey indicates that 39% of obstetricians consider conservative management as the primary management. Notably, conservative management was inconsistent among respondents (Cal, Ayres-de-Campos et al. 2018).

Placental pouch closure looks to be an attractive and effective surgical procedure for conservative management of placenta accreta (Zahran, Elsonbaty et al. 2020). In their series of 60 Placenta accreta cases reported that by using this technique,59 out of the 60 enrolled cases, the uterus was successfully conserved and there were no cases of maternal mortality or severe morbidities related to the procedure.

Major blood supply of the uterus comes from the uterine artery, so bilateral uterine artery ligation (UAL) before delivering of the placenta greatly decreasing the blood loss(Lin, Lin et al. 2019). Simultaneously, the ovarian blood flow has not been affected and consequently no changes in ovarian reserve markers occurred, so it is considered one of preserving fertility surgical technique (Verit, Çetin et al. 2019).

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
16 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • • Previous operations
  • Gestational age (28 weeks)
  • Prenatally suspected PAS based on sonographic and/or MRI findings and/or intrapartum diagnosis of PAS.
  • Authorization to participate in the study

排除标准

  • • Coagulopathies
  • Chronic renal or hepatic impairment (baseline first trimester labs are beyond normal range for pregnancy)
  • Delivery in an outside hospital (patients referred for ongoing massive bleeding due to PAS)
  • Patients coming in emergency condition with bleeding or in labour.

结局指标

主要结局

bilateral uterine artery ligation

时间窗: 30 months

1\. The effect of bilateral uterine artery ligation and estimation of blood volume loss (VMBL): direct measurement of blood loss in volume units (mL);

次要结局

未报告次要终点

研究者

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

Mostafa Hussein Abouzeid Ahmed

Principal Investigator

Assiut University

研究点 (2)

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