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临床试验/NCT04660578
NCT04660578已完成不适用

A.Chohan Continuous Squeezing Suture (ACCSS) for Controlling Hemorrhage From the Lower Uterine Segment at the Cesarean Section for Placenta Previa / Accreta: a Case Series

King Edward Medical University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年2月12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
30
试验地点
2
主要终点
Peripartum hysterectomy

研究概览

简要总结

Placenta praevia and accreta spectrum disorders are rising in incidence due to increased rate of repeat caesarean sections. Peripartum hysterectomy remains the only definitive treatment of massive postpartum haemorrhage related to this condition. A multitude of conservative treatments is described in literature, which includes pelvic devascularization under radiological control, myometrial resection with placenta in situ, and various suturing techniques some involving inversion of cervix. Variable success rates are described, but search continues for a simple, safe and effective treatment. Such a surgical technique i.e. A. Chohan Continuous Squeezing Suture (ACCSS) is described in this study for controlling haemorrhage from the lower uterine segment at caesarean section for placenta praevia and accrete spectrum disorders.

详细描述

Postpartum haemorrhage (PPH) has always been a prominent cause of maternal morbidity as well as mortality worldwide, with uterine atony as the leading cause and peripartum hysterectomy as the only definitive treatment option . Researchers are struggling throughout the years to find a treatment modality other than hysterectomy, which has least morbidity and potential to preserve fertility. In an attempt to find a non-radical treatment for PPH due to uterine atony, a novel uterine compression suture was introduced in 1997. The time then witnessed emergence of a series of its variants from all over the world which effectively lowered the incidence of peripartum hysterectomy from uterine atony.

Meanwhile the incidence of placenta praevia and placenta accreta spectrum disorder rose dramatically across the globe because of rising incidence of repeat caesarean sections. Placenta accreta spectrum has opened up a new era in the history of PPH, as forcible separation of adherent placenta leads to massive bleeding from placental bed. Peripartum hysterectomy has once again emerged as gold standard treatment for this variety of PPH with its overall morbidity of 40-50%, and mortality of 7-10% in case of placenta percreta. The fear of placental bed bleeding has led to the development of conservative managements like "leaving the placenta in situ approach" with its wide range of mild to severe, and serious morbidities. The conservative surgical techniques i.e. The triple P procedure, one step conservative surgery approach, have also used the concept of non-separation of placenta and have instead adopted resection of myometrium with placenta in situ. These surgeries involve devascularisation of deep pelvic / major abdominal vessels and ligation of complex arterial anastomosis making the procedure technically difficult. Moreover, the devascularisation is done under extensive and expensive interventional radiological equipment which places the procedures out of reach for the routine setups particularly in the under developed countries. Another conservative surgical technique i.e. stepwise surgical approach, which described separation of placenta also mainly relied upon devascularisation of pelvic organs by bilateral ligation of anterior branch of internal iliac artery rather than elaborating the details of technique of controlling haemorrhage at the actual bleeding site.

Three corners stones of uterine compression sutures have been described in literature i.e. simplicity, safety and efficacy and no such suturing technique so far is published. Hence, it's the time for innovation in the treatment of placenta praevia and PAS. In this study, we report our own experience of a conservative surgical technique i.e. A. Chohan Continuous Squeezing Suture (ACCSS) application in the lower uterine segment during caesarean section in profusely bleeding patients with placenta praevia and placenta accreta spectrum without involvement of urinary bladder and other pelvic organs. This surgical technique takes on the separation of placenta and describes a placental bed suturing without involvement of interventional radiology as well as ligation of deep pelvic vessels. The objective of this study is to assess the simplicity, safety and efficacy of this surgical technique in the management of PAS, with the intension to develop a simple, safe and effective alternative to hysterectomy.

Surgical Procedure:

After opening the abdomen, a transverse incision was given in the lower uterine segment after ascertaining the site of easy fetal access avoiding the placenta as far as possible. After the delivery of the baby, the uterus was exteriorized and routine uterotonics were given. The placenta was left in-situ and incision margins were held with Green-armitage forceps to minimize bleeding.

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
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All consenting patients at 32 weeks of gestation, with the diagnosis of placenta previa and placenta accreta spectrum without involvement of bladder and other pelvic organs.
  • Woman who wished to conserve the uterus.

排除标准

  • Patients were excluded from the study if an emergency cesarean section was done due to severe antepartum hemorrhage before the plan of surgery.
  • Patients with Placenta accreta spectrum with bladder and/or other pelvic organ involvement.

结局指标

主要结局

Peripartum hysterectomy

时间窗: 24 hours

Number of peripartum hysterectomies within the study group

次要结局

  • Estimated blood loss(duration of surgery in minutes)
  • Number of units of blood transfusions(First 24 hours)
  • Application time of suture in minutes(within 20 minutes)
  • Duration of stay of the participants in hospital in days(7 days)
  • Number of patients with secondary postpartum hemorrhage(6 weeks)
  • Prevalence of maternal mortality(6 weeks)
  • Number of patients requiring other conservative medical and surgical treatments(Duration of surgery in minutes)
  • Number of patients with urinary bladder trauma and its complication(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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