Conservative Management of Placenta Accreta Spectrum With or Without Internal Iliac Ligation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cesarean hysterectomy rate
研究概览
简要总结
In the current study, the investigators aimed to compare the benefits of internal iliac ligation in placenta accreta spectrum
详细描述
This randomized control trial will be conducted at Tanta University hospital, Egypt, from 2022 to 2024. Tanta University Hospital is considered the main tertiary hospital at the center of Nile Delta .
Cases, suspected to have PAS, are recruited from the outpatient clinic, and subsequently transferred for ultrasonod gray scale and dopplar for assessment of placental location, invasion and commont on the fetus .
Cases are diagnosed to have PAS by the following criteria Placenta lacunae , Loss of clear zone , Bladder wall interruption, uterovesical hypervascularity and increased vascularity in inferior part of lower uterine segment extending into parametrial region9 will be included in the study. MRI will be done if ultrasonod isn't conclusive , cases with posterior placenta, depth of placental invasion, relationship to posterior bladder wall and presence of parametrial invasion .
All cases will be subjected to the following:
- A written consent will be obtained from the patients after informing them about the risk of intrapartum and postpartum hemorrhage, the need for blood transfusion, and the possibility of hysterectomy if needed to stop massive blood loss. The consent is approved by the medical ethical committee of Tanta University Hospital.
- Full history taking with special attention on:
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)
盲法说明
Patients only will be masked
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age under 35 years old.
- •Prenatally diagnosed placenta accreta .
- •Planned caesarean section ≤ 37 wks .
- •≤ previous 3 ceserian sections .
- •Placenta accretta spectrum grade 1 , 2 ,3 .
- •Patients who want to preserve their fertility.
- •Patients who refuse hysterectomy .
排除标准
- •Cases with high risk of intraoperative blood loss as hemorrhagic disorders and thrombocytopenia .
- •Cases on anticoagulant therapy.
- •Patients who completed her family.
- •Hemodynamicaly unstable patients.
- •Finally cases who refused to get enrolled in the study.
研究组 & 干预措施
Study group
Conservative management of PAS with Ligation of the bilateral internal iliac arteries
干预措施: Ligation of the bilateral internal iliac arteries (Procedure)
Control group
Conservative treatment with Shehata's technique and no internal iliac ligation
干预措施: Shehat's technique (Procedure)
结局指标
主要结局
Cesarean hysterectomy rate
时间窗: 6 months
The success of procedure in prevention of hysterectomy
Intraoperative blood loss
时间窗: 6 months
the volume of blood collected in the suction apparatus, excluding the volume of liquor collected, this will be done by meticulous recording of the blood volume in the suction apparatus before opening the uterus and then calculating the exactly added amount of liquor, so that it becomes excluded from the calculation) to the calculated volume of blood obtained from the pre and postoperative difference in weight of the towels and drapes placed beneath the patients, using the following formula: (WET Item Gram Weight - DRY Item Gram Weight¼milliliters of blood within the item) .
次要结局
- Operative and postoperative complications(6 months)
- Operative time(intraoperative)
研究者
Ayman S Dawood, MD
Assistant professor
Tanta University