Topical Adrenaline Versus Warm Saline Solution for Minimizing Intraperitoneal Bleeding During Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS): A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- control of intra-operative bleeding from surgical field.
研究概览
简要总结
Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage . Currently, more than 90% of women diagnosed with PAS also have a placenta praevia , and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . Maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases .
Adrenaline has also been demonstrated to be a reasonable hemostatic agent because of its low cost, low risk, powerful vasoconstrictor, and platelet aggregation. Topical use of adrenaline is an effective and reasonable hemostatic agent in tonsillectomy.
详细描述
- Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.
- Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine , Cairo University.
This is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (Medcalc ®) .
Group A : Topical adrenaline group (n=42)
Group B : Warm saline Group (control) (n=42)
The aim of the study is to evaluate the efficacy of topical adrenaline for decreasing intraperitoneal bleeding during caesarian section for placenta previa/ Accreta spectrum (PAS).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age from 18 to 40 years.
- •Pregnant patients with placenta previa .
- •Placenta accrete spectrum.
- •Vitally stable .
排除标准
- •Vitally unstable .
- •Massive pre- or intra-operative bleeding.
- •Medical disorders ( e.g. : hypertension , cardiac .... )
研究组 & 干预措施
Topical Adrenaline Group
Topical adrenaline group
干预措施: Topical adrenaline (Drug)
Warm saline Group
Warm saline Group
干预措施: Warm saline (Drug)
结局指标
主要结局
control of intra-operative bleeding from surgical field.
时间窗: 30 minutes after application of topical drug
control of intra-operative bleeding from surgical field if bleeding stopped , or minimal oozing , towel are not soaked with blood and improvement of general condition with no hemoglobin drop.
次要结局
- Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy(if bleeding continued 30 minutes after topical drugs)
- immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)(24 hours after delivery)
研究者
Bassiony Dabian
lecturer of obstetrics and gynecology
Cairo University