Cervico-Isthmic Compression Suture Versus Anterior Wall Uterine Resection in Cases of Morbidly Adherent Anterior Situated Placenta
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- estimated blood loss
研究概览
简要总结
Placenta accreta is defined as abnormal trophoblast invasion of part or the entire placenta into the myometrium of the uterine wall. Placenta accreta spectrum (PAS), formerly known as morbidly adherent placenta, refers to the range of pathologic adherence of the placenta, including placenta increta, percreta, and accreta.
An important risk factor of placenta accreta is placenta previa in the presence of a uterine scar. Placenta previa is an independent risk factor for placenta accreta.Additional reported risk factors for placenta accreta include increased maternal age and multiparity, other prior uterine surgery, prior uterine curettage,uterine irradiation, Asherman syndrome, uterine leiomyomata, uterine anomalies, hypertensive disorders of pregnancy and smoking. (1,2) Maternal morbidity and mortality can occur because of severe and sometimes life-threatening hemorrhage, which often requires blood transfusion also and rates of maternal death are increased for women with PAS. Additionally, patients with PAS are more likely to require hysterectomy at the time of delivery or during the postpartum period and have longer hospital stays states.(3) According to FIGO Classification of PAS Disorders 2019 There are three grades. Grade 1: abnormally adherent placenta (placenta adherent or accreta) - attached directly to the surface of the middle layer of the uterine wall (myometrium) without invading it, Grade 2: abnormally invasive placenta (increta) - invasion into the myometrium and Grade 3: abnormally invasive placenta (percreta) invasion may reach surrounding pelvic tissues, vessels and organs.(4) Nowadays, fertility sparing and conservative methods can be applied. These methods include placenta left in situ, cervical inversion technique , triple-P procedure, cervico-isthmic compression suture and anterior wall uterine resection
详细描述
Study Design & Area:
Randomized controlled trial (RCT) of pregnant women recruited from Department of Obstetrics and Gynecology Mansoura University Hospitals during September 2020 until September 2021 and may be extended if needed.
The study groups will undergo:
Informed consent
History:
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1- Patient with FIGO classification of PAS disorders Grade 1 & Grade 2 which diagnosed by :
- •Loss of normal hypoechoic retroplacental zone.
- •Multiple vascular lacunae (irregular vascular spaces) within placenta, giving "Swiss cheese" appearance.
- •Retroplacental myometrial thickness of less 1 mm. 2- Patient welling to preserve fertility.
排除标准
- •1- Patient with FIGO classification of PAS disorders Grade 3 (interruption of the hyperechoic border between the uterine serosa and bladder by US).
- •2- Age : >40 years old. 3- Patient has medical disorders: cardiac disease, uncontrolled DM, chronic renal disease, chronic liver disease.
- •4- Patient who refuse to participate in the study.
结局指标
主要结局
estimated blood loss
时间窗: from the start of uterine incision till closure of uterine wall
1. The amount of blood drawn into the storage jar during surgery (suction apparatus). 2. The weight of blood-soaked gauze pads, gauzes, and surgical dressings minus their preoperative weight, and corresponding conversion according to the proportion of 1.05 g in weight to 1 ml in volume.
次要结局
- complication rate(from the start of induction of anesthesia till 24 hours after the end of surgery)
- hemoglobin deficit(from the induction of anesthesia till 2 hours after the end of surgery)
研究者
Mohamed Taman
lecturer
Mansoura University Hospital