Role of Ligation of the Anterior Division of the Internal Iliac Artery in Conservative Management of Patients Diagnosed With Partial or Focal Placenta Accreta Spectrum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Amount of blood loss 24 hours post-operative
研究概览
简要总结
The patients will be divided into 2 groups:
Group (A) - Study group: Cases managed by lower segment resection with ligation of the anterior division of the internal iliac artery
Group (B) - Control group: Cases managed by lower segment resection without ligation of the anterior division of the internal iliac artery
The following operative details will be recorded:
- Estimation of total blood loss
- Pre and 24-h post-operative hemoglobin (g/dl).
- The need for blood transfusion and its amount intra or postoperative will be recorded
- Operative time and postoperative hospital stay will be recorded.
- Close post-operative monitoring of the patients' vital signs, drain output, and urine output
- Presence or absence of intraoperative complications; bladder, ureteric, bowel, or vascular injuries will be recorded.
- Monitoring for postoperative morbidities
详细描述
The patients will be divided into 2 groups:
Group (A) - Study group: Cases managed by uterine lower segment resection with ligation of the anterior division of the internal iliac artery (4 cm distal to the bifurcation of the common iliac artery).
Group (B) - Control group: Cases managed by uterine lower segment resection without ligation of the anterior division of the internal iliac artery.
In both groups, bilateral uterine artery ligation at 2 levels will be done; bilateral ligation at a level below the lower most placental part, followed by bilateral uterine artery ligation at the level of the hysterotomy incision.
The following operative details will be recorded:
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 20-40 years old.
- •Pregnancy of singleton living fetus.
- •Previous one or more cesarean sections.
- •Gestational age: > 36 weeks.
- •Elective termination of pregnancy.
- •Cases not requiring preoperative blood transfusion.
- •Cases with focal area of placental adherence or invasion leaving sufficient healthy myometrial tissue for uterine repair and preservation.
- •The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesical hypervascularity".
排除标准
- •Multifetal pregnancy.
- •More than four previous sections.
- •Emergency termination of pregnancy due to antepartum hemorrhage, placental separation or rupture uterus.
- •Intrauterine fetal death.
- •Women with history of any medical disorder with pregnancy eg. Gestational diabetes and hypertension.
- •Premature rupture of membranes.
- •Cases misdiagnosed as placenta accreta by ultrasound preoperatively, and spontaneous full placental separation occurred intraoperative. "will be excluded before randomization"
- •Cases with PAS with total invasion involving all placental lobules.
- •Cases who will be managed by cesarean hysterectomy due to uncontrolled intraoperative bleeding.
结局指标
主要结局
Amount of blood loss 24 hours post-operative
时间窗: 24 hours post-operative
Amount of blood loss 24 hours post-operative
Amount of blood loss intra-operative
时间窗: during operation
Amount of blood loss intra-operative
次要结局
- Operative time(during operation)
- Number of blood units transfused(within 24 hours after surgery)
研究者
Abdalla Mousa
Principal Investigator
Cairo University