Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to the Segmental Resection Approach in Patients With Placenta Accreta Spectrum: A Prospective Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 主要终点
- Number of Participants who had Bladder injuries
研究概览
简要总结
The study will compare a modified surgical approach for preserving fertility and minimizing hemorrhage in morbidly adherent placenta during cesarean section with a cervical tourniquet against uterine artery ligation.
详细描述
Study Design and Setting This was prospective interventional study that comprised the medical data of 82 pregnant women with placenta accreta who had caesarean section. . This study will be carried out In the Department of Obstetrics and Gynecology, Minia Maternity University Hospital (MMUH) .
after being approved by the local ethical Committee; If placenta accreta was clinically verified preoperatively, all parturients were informed of the option of a hysterectomy. After receiving written, formal consent . After receiving documented formal consent. The study included all patients who had a scheduled cesarean procedure for placenta accreta. Obstetrical imaging either verified or strongly suspected the diagnosis. During the prenatal period, a senior sonographer evaluated all patients using ultrasonography and color Doppler technology. An ultrasonographic assessment was done. Each patient was evaluated for retroplacental sonolucent zones, vascular lacunas, myometrial thinning, bladder line disruption, and exophytic masses . The Color Doppler scan evaluated placental lacunar flow, hypervascularity in the vesicouterine interface, and continuous retroplacental venous complex structures. A 3D Doppler scan was used to assess hypervascularity of the uterine serosa and bladder interphase, as well as uneven intraplacental vascularization
Assessment :
To assess the effectiveness of the proposed management strategy, participants were separated into two groups. In Group 1 (n = 41), a cervical tourniquet was used systematically. In Group 2 (n=41), uterine artery ligation was performed prior to segmental resection for uterine preservation surgery
Surgical scenarios :
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
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed sonographically to have placenta accreta spectrum .
- •Pregnancy is singleton and fetus is alive.
- •Elective caesarean section done from 36 gestational weeks
排除标准
- •Patients requesting hysterectomy
- •Coexisting uterine pathology such as fibroids or gynaecological malignancies
- •Patients with bleeding diathesis.
- •Morbid obesity of BMI >
- •Patients having labour pains or vaginal bleeding before scheduled intervention
结局指标
主要结局
Number of Participants who had Bladder injuries
时间窗: intraoperative until 2 weeks post operative
Number of Participants who had Bladder injuries
hospital stay
时间窗: postoperative until 10 days after surgery
recording duration of hospital stay after surgery
surgical diagnosis
时间窗: intraoperative
strategy to preserving the uterus when managing placenta accreta versus hysterectomy
packed red blood cells transfusion
时间窗: intraoperative until 24 hours after surgery
recording amount of red blood cell transfused
fresh frozen plasma (FFP) transfusion
时间窗: intraoperative until 24 hours postoperative
recording amount of FFP transfusion
Number of Participants who had bowel injury
时间窗: intraoperative until 2 weeks post operative
Number of Participants who had bowel injury
surgical site infection
时间窗: 24 hours until 1 month after surgery
record the presence of wound infection
ICU admission
时间窗: immediate postoperative until 5 days after surgery
recording the number of patients admitted to the ICU
repair time
时间窗: intraoperative
recording length of defect repair from placental separation until uterine wall closure
urine output
时间窗: intraoperative
recording amount of urine output
post-operative hemoglobin
时间窗: postoperative within 6 hours from surgery
recording amount of hemoglobin
Estimated blood loss
时间窗: intraoperative
recording amount of blood loss
HDU high dependency unit admission
时间窗: postoperative until 10 days after surgery
recording the number of patients admitted to high dependency unit
operation time
时间窗: intraoperative
recording total time of the surgery
Number of Participants who had ureteral injuries
时间窗: intraoperative until 2 weeks post operative
Number of Participants who had ureteral injuries
internal iliac artery ligation
时间窗: intraoperative
recording if the internal iliac artery ligated whether it was unilateral or bilateral
pre-operative hemoglobin
时间窗: preoperative
recording amount of hemoglobin
次要结局
未报告次要终点
研究者
Mohamed Hassan Mohamed Abdel Ghfar
lecturer
Minia University