Placenta Accreta Spectrum International Database (PAS-ID): Project Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Failure of conservative management of placenta accreta spectrum (PAS)
研究概览
简要总结
Aim of this project is to study diagnosis and management approaches of PAS and to assess safety and efficacy of different conservative approaches compared to planned hysterectomy. We aim at improving selection process and patient counselling for women who would like to consider alternatives to hysterectomy. To achieve these objectives, creation of an international database collected by PAS-experienced centers that represent all continents would promote conduction of large studies that provide higher level of evidence on different options of management of PAS
详细描述
Placenta accreta spectrum (PAS) is a complex placentation disorder associated with high maternal morbidity; complications of PAS include hemorrhage, blood transfusion, multiple organ failure, and death
- The incidence of PAS has been increasing steadily in response to the increase in cesarean delivery rate
- Available evidence supports planned preterm cesarean hysterectomy with the placenta left in situ as the standard treatment of PAS
However, hysterectomy is traumatic to many women due to its operative sequences, impact on fertility, and disruption of self-image. Therefore, several conservative management options were proposed as an alternative to hysterectomy
- Although many of conservative approaches yielded satisfactory results, their implementation as a part of standard protocols has been limited
- There is primarily because evidence supporting most of these approaches is limited to case series, which is insufficient to support their safety. As a sequence, clinical trials are challenged by the lack of the margin of safety that would support ethical rationale of future studies. Availability of large multicenter studies is anticipated to provide robust evidence regarding optimal management of PAS and appropriate patient selection for conservative management
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women diagnosed with PAS, aged between 18 to 48 years.
- •Women should be delivered by the corresponding center.
排除标准
- •Inadequate follow-up
- •Authorization to use anonymous patient data for research purposes.
结局指标
主要结局
Failure of conservative management of placenta accreta spectrum (PAS)
时间窗: from delivery to 6 months after delivery
Need for emergency or delayed hysterectomy following trial of conservative treatment
次要结局
- Maternal blood loss(From delivery and up to 24 hours postpartum)
- Incidence of urinary injury during intraoperative management of placenta accreta spectrum (PAS)(From delivery and up to 6 weeks postpartum)
- Admission to maternal intensive care unit (ICU) after management of placenta accreta spectrum (PAS)(From delivery and up to 6 weeks postpartum)
- Infectious morbidity after management of placenta accreta spectrum (PAS)(From delivery and up to 6 weeks postpartum)
研究者
Sherif Abdelkarim Mohammed Shazly
MBBCh, MSc
Assiut University