Beni-Suef University Hospital Simplified Conservative Approach for Managing Placenta Accreta Spectrum: RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Amount of blood loss
研究概览
简要总结
To evaluate the efficacy of modified uterine artery ligation and myometrial compression as a conservative measure in improving the prognosis of the morbidly adherent placenta.
详细描述
According to the International Federation of Gynecology and Obstetrics (FIGO) guidelines, the principal surgical strategy to prevent excessive bleeding related to placenta accreta syndrome is to leave the placenta in situ and perform a primary peripartum hysterectomy at delivery. A hysterectomy may not be preferred by patients wishing to preserve fertility and is detrimental to multiple aspects of the pelvic floor, bowel, and physical functions.
Surgical principles in placenta accreta syndrome include avoiding disruption of the hypervascular placenta, stepwise devascularization, early and comprehensive blood product transfusion, and judicious use of interventional radiologic techniques such as vascular embolization.
Conservative management describes any approach whereby hysterectomy is avoided
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization will be done by online research randomizer as follows (https://www.randomizer.org/about/ ):
2 Sets of 86 Unique Numbers Per Set Range: From 1 to 172
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age more than 28 weeks as determined by LMP and ultrasound.
- •Placenta previa as confirmed by ultrasound.
- •Clinically stable with no or mild vaginal bleeding.
- •No evidence of fetal compromise.
- •Patient consent.
排除标准
- •Vaginal bleeding
- •Medical disorders
研究组 & 干预措施
O- lreay technique group
Group A: In which 86 patients will have bilateral uterine artery ligations as described by O- lreay technique in addition to standard conservative methods. Briefly, two large vicryl stitches were passed using a large-sized needle below and lateral to the lower edge of the uterine incision angle in an anteroposterior direction and then redirected from back to the front through the avascular window in the posterior leaf of the broad ligament just lateral to the uterine border taking care to avoid injury to bowel posteriorly or bladder/ureter anteriorly. The stitches were tied securely anteriorly
干预措施: O, lreay suture (Procedure)
Modified O- lreay technique group
Group B: which will include 86 patients we will do our simplified approach which includes;
- After placental separation; try to grasp the lower segment or cervical flap.
- Close uterine cavity by continuous vicryl no 1 suture.
- Do 3 to 4 mattress sutures as the second layer of the uterus.
- Do uterine ligation with compression of the lower uterine segment (Modification of O, lreay suture) as demonstrated below:
- Pack Douglas- pouch with a towel.
- Straight the used vicryl needle mostly no 1.
- Try to compress and approximate anterior and posterior uterine walls.
- Start from anterior to posterior 3- 4 cm medial to lateral uterine margin and then pass from posterior to anterior through avascular area in the broad ligament.
干预措施: modified O, lreay suture (Procedure)
结局指标
主要结局
Amount of blood loss
时间窗: 6 hours postoperatively
The primary outcome for the study is the total volume of blood loss in the intra and postoperative period.
次要结局
- Maternal mortality(24 hours postoperatively)
- Maternal morbidity(24 hours post operatively)
研究者
Nesreen Abdel Fattah Abdullah Shehata
Professor
Beni-Suef University