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临床试验/NCT02590484
NCT02590484Unknown不适用

The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta: a Prospective Study

Minia University2 个研究点 分布在 1 个国家开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
试验地点
2
主要终点
Successful control of postpartum haemorrhage (PPH)

研究概览

简要总结

Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections. The aim of this study is to evaluate the efficacy and safety of the use of the cervix as a natural tamponade in controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.

详细描述

Background: Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. The maternal mortality in women with placenta accreta may reach as high as 7-10%. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections, including uterine packing with gauze, balloon tamponades, the B-Lynch suture, insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries, but there is a wide variation in the success rate of these maneuvers. In a case report, Dawlatly et al. (2007) described a simple technique of suturing an inverted lip of the cervix over the bleeding placental bed that was successful in controlling the bleeding, saving the patient's life, and preserving her uterus.

The objective of this trial is to evaluate the safety and efficacy of the use of this Dawlatly stitch as a natural tamponade for controlling postpartum haemorrhage in cases of placenta previa and/ or placenta previa accreta.

研究设计

研究类型
Interventional
主要目的
Treatment

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

  • All participating women had one or more previous cesarean deliveries.
  • were diagnosed with placenta previa and/ or placenta previa accreta by ultrasound. When the ultrasound result was not conclusive for placenta accreta, MRI was performed.
  • All participating women desired to preserve their fertility
  • Patients with focal (partial) placenta previa accreta/ placenta previa.

排除标准

  • placenta percreta.
  • diffuse placenta accreta or increta.
  • uncontrollable postpartum hemorrhage.

结局指标

主要结局

Successful control of postpartum haemorrhage (PPH)

时间窗: Intra-operative and up to 24 hours postpartum

Control of PPH and vaginal bleeding after employing the technique

Number of cases undergoing hysterectomy to control PPH

时间窗: Intra-operative and up to 24 hours postpartum

Failure of the technique to stop PPH and need for hysterectomy to stop the bleeding

Incidence of complications

时间窗: short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Rabie Abdelraheim

Dr Ahmed Rabie Abdelraheim, lecturer of Obstetrics And Gynaecology

Minia University

研究点 (2)

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