Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Uterine conservation
研究概览
简要总结
The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.
详细描述
Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with diagnosis of placenta accreta (US or MRI based diagnosis)
- •Women who decline hysterectomy
- •Pregnancy at 28 weeks of gestation or beyond
- •Women who accept to participate in the study
排除标准
- •Emergency Cesarean delivery (women with active bleeding)
- •Women with cardiac diseases
- •Women with coagulopathy
结局指标
主要结局
Uterine conservation
时间窗: Intra-operative (during the time of Cesarean delivery)
Successive Uterine conservation; no peripartum hysterectomy needed
次要结局
- Severe primary postpartum hemorrhage(From delivery of the fetus to 1 hour after delivery of the fetus)
- Primary postpartum hemorrhage(From delivery of the fetus to 1 hour after delivery of the fetus)
- Bladder injury(Intra-operative (during the time of Cesarean delivery))
- Surgical site infection(Up to 2 weeks after Cesarean delivery)
- Bowel injury(Intra-operative (during the time of Cesarean delivery))
- Drop in hemoglobin level(Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery))
研究者
Sherif Abdelkarim Mohammed Shazly
Assistant lecturer, OBGYN department; principal investigator
Assiut University