Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- intraoperative blood loss
研究概览
简要总结
The placenta accreta spectrum (PAS)is one of the most common reasons for cesarean hysterectomy Which associated with high rates of severe maternal morbidity (40%-50%), with reported mortality rates up to 7%. And, a cesarean hysterectomy might not be considered first-line treatment for women who have a strong desire for future fertility.
Conservative management of PAS defines all procedures that aim to avoid peripartum hysterectomy and its related morbidity and consequences.
The main types of conservative management which have been described in the literature: the extirpative technique (manual removal of the placenta); leaving the placenta in situ or the expectant approach; one-step conservative surgery and the Triple-P procedure. These methods have been used alone or in combination and in many cases with additional procedures such as those proposed by interventional radiology.
详细描述
patients were allocated to one of two groups. Group (I): patients will be received N&H technique Group (II): patients will be received cesarean hysterectomy. In the N&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed as follow: (i) 100-cm Vicryl no. 1 was thrown to form two nearly equal parts (each 50 cm) on a blunt semicircular 70-mm needle, the curve of the needle was straightened.
(ii) The needle transfixed the right side of the uterine wall from anterior to posterior, about5 cm below the hysterotomy incises posterior, then the needle transfixed the left side of the uterine wall from posterior to anterior, about 2 cm below the hysterotomy incision.
(iii) another transverse compression suture undertook above the first one by 3 cm and below the hysterotomy incision by 2 cm.
(iv) At the end of the suture application and before tying the knots, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon (Medical Industries, 10th of Ramadan City, Egypt) was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 80 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures . Only one catheter was used for tamponade.
(v) Lastly ties the sutures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
no masking
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •all pregnant women with a full-term pregnancy with placenta accreta spectrum
排除标准
- •Patients with a cardiac, hepatic, renal or thromboembolic disease.
- •patients with pelvic endometriosis and adnexal mass.
- •those presented with severe antepartum hemorrhage will be excluded
- •known coagulopathy
- •twin pregnancy
研究组 & 干预措施
cesarean hysterectomy
Elective Cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. The operation will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician.
干预措施: cesarean hysterectomy (Procedure)
N&H sandwich technique
In the N&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed
干预措施: N&H sandwich technique (Procedure)
结局指标
主要结局
intraoperative blood loss
时间窗: during the operation
measures the intraoperative blood loss by direct and gravimetric methods
次要结局
- need of other surgical maneuvers(during the operation)
- postoperative blood loss(24 hours postoperative)
- need of blood transfusion(ist 24 hours postoperative)
- operative time(during the operation)
研究者
hany farouk
lecturer
Aswan University Hospital