A Comparison Between Bladder Dissection Before and After Uterine Incision During Cesarean Section for Placenta Accreta Spectrum: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- o Blood loss
研究概览
简要总结
The worldwide incidence of placenta accreta spectrum is increasing, following the trend of rising caesarean delivery. It is an heterogeneous condition associated with a high maternal morbidity and mortality rate (Jauniaux et al., 2018).
caesarean hysterectomy is considered the gold standard for the treatment of placenta accreta. Also this radical approach is associated with high rates of severe maternal morbidity as hemorrhage and insult to surrounding organs during surgery (Hoffman et al., 2010).
Surgeons should be able to dissect the bladder safely and confidently through minimally invasive techniques, to avoid surgical injury, it is important to use anatomic landmarks, minimize the use of cauterization (Farhat and Casale, 2018).
All centers are encouraged to develop guidelines to manage the potential urologic complications of these cases tailored to their resources (Taneja and Shah, 2017).
This study aims to evaluate the timing of bladder dissection in caesarean section in patient with placenta accreta spectrum.
详细描述
Objective:
Try to provide preliminary data to judge between two different approaches during caesarean section for morbidly adherent placenta, that's are bladder dissection before and after uterine incision as regard operative time, blood loss, and incidence of urological injuries.
Research Question:
- Does bladder dissection after uterine incision in caesarean sections with PAS avoids bladder injuries compared to bladder dissection before uterine incision and does it affects operative time and blood loss.
Research hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with BMI at or under 35kg/m2
- •Women with history of at least previous two caesarean section
- •Gestational age more than 32 weeks with viable fetus.
- •Women with any degree of placenta previa.
- •Women with placenta falling in the PAS.
- •Willing and able to provide informed consent.
排除标准
- •o History of urinary bladder injury.
- •History of urinary or renal disorders
- •Women with coagulation disorders or on anticoagulation therapy.
- •Patients who are hemodynamically unstable before skin incision
研究组 & 干预措施
group A
40 patients will have bladder dissection at the start of caesarean section for patient with morbidly adherent placenta
干预措施: bladder dissection in placenta accreta spectrum (Procedure)
group b
40 patients will have bladder dissection after closing uterine incision and just before clamping uterine artery in case of caesarean hysterectomy
干预措施: bladder dissection in placenta accreta spectrum (Procedure)
结局指标
主要结局
o Blood loss
时间窗: 1 year
assessed by number of soaked towels and suction reservoir)
次要结局
未报告次要终点