Beni-Suef University Hospital Simplified Conservative Approach for Managing Placenta Accreta Spectrum: RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Amount of blood loss
研究概览
简要总结
To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta.
详细描述
According to the International Federation of Gynecology and Obstetrics (FIGO) guidelines, the principal surgical strategy to prevent excessive bleeding related to placenta accreta syndrome is to leave the placenta in situ and perform a primary peripartum hysterectomy at delivery. A hysterectomy may not be preferred by patients wishing to preserve fertility and is detrimental to multiple aspects of the pelvic floor, bowel, and physical functions.
Surgical principles in placenta accreta syndrome include avoiding disruption of the hypervascular placenta, stepwise devascularization, early and comprehensive blood product transfusion, and judicious use of interventional radiologic techniques such as vascular embolization.
Conservative management describes any approach whereby hysterectomy is avoided
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be done by online research randomizer as follows (https://www.randomizer.org/about/ ):
2 Sets of 86 Unique Numbers Per Set Range: From 1 to 172
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age more than 28 weeks as determined by LMP and ultrasound.
- •Placenta previa as confirmed by ultrasound.
- •Clinically stable with no or mild vaginal bleeding.
- •No evidence of fetal compromise.
- •Patient consent.
排除标准
- •Vaginal bleeding
- •Medical disorders
结局指标
主要结局
Amount of blood loss
时间窗: 6 hours postoperatively
The primary outcome for the study is the total volume of blood loss in the intra and postoperative period.
次要结局
- Maternal mortality(24 hours postoperatively)
- Maternal morbidity(24 hours post operatively)
研究者
Nesreen Abdel Fattah Abdullah Shehata
Professor
Beni-Suef University