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临床试验/NCT05070689
NCT05070689Unknown不适用

Placenta Accreta Spectrum Disorders: A. Chohan Continuous Squeezing Suture (ACCSS) for Controlling Haemorrahge From Lower Uterine Segment at Caesarean Section

Sharif Medical Research Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年11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
20
试验地点
2
主要终点
Peripartum Hysterectomy

研究概览

简要总结

Placenta Accreta Spectrum (PAS) 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. Researchers have described conservative treatments in the form of 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. The objective of this study is to assess the simplicity, safety and efficacy of A. Chohan Continuous Squeezing Suture (ACCSS) in the management of PAS.

详细描述

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 emerged as gold standard treatment for this variety of PPH (3 folds rise over uterine atony) 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 management like "leaving the placenta in situ approach" with its wide range of mild to severe, and serious morbidities . The conservative surgical techniques (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 (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.

Rationale of ACCSS ACCSS is a novel suturing technique addresses the management of placenta praevia and PAS following the orthodox approach of separation of placenta, taking the challenge of controlling massive haemorrhage. The rational of ACCSS is; i. Placental bed is the ultimate area of concern in women with placenta praevia and PAS, and it generally spreads over the whole inner surface of lower uterine segment, but the placental attachment and bleeding area upon its separation does not extend onto the internal os and into the vagina.

ii. Lower uterine segment is thin, flexible, squeezable and holds the suture well.

iii. Internal cervical os is a fixed structure, and has a ring with sufficient strength to function as anchor to the suture.

iv. Taking half thickness of internal cervical os into suture does not alter the anatomy and uterine drainage remains unaffected.

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

  • The women at 32 weeks' gestation with central (anterior dominant, posterior) placenta praevia.
  • The women with Placenta Accreta Spectrum disorders having myometrial invasion limited to the uterine serosa (Grade 1, 2, and 3a) without involvement of urinary bladder and other pelvic organs.
  • The women wishing to conserve the uterus at the time of caesarean section.

排除标准

  • The patients with placenta accreta spectrum disorder with bladder and other organs involvement (Grade 3b, 3c) diagnosed prenatally and during caesarean section.
  • The patients with laterally situated right and left placentae.
  • The recruited patients who required emergency caesarean section.

结局指标

主要结局

Peripartum Hysterectomy

时间窗: 24 hours

Absolute number of peripartum hysterectomies within the study group

次要结局

  • Estimated blood loss(First 24 hours)
  • Maternal mortality(6 weeks)
  • Uterine complications(6 weeks)
  • Secondary postpartum hemorrhage(6 weeks)
  • Application time of suture in minutes(within 20 minutes)
  • Urinary tract trauma and its complication(6 weeks)
  • Number of units of blood transfusions(First 24 hours)
  • Intensive care unit admissions(7 days)
  • Duration of stay in hospital(7 days)

研究者

发起方
Sharif Medical Research Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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