A Comparative Study Between Rectal and Intrauterine Misoprostol Administration in the Reduction of Blood Loss During and After Elective Cesarean Delivery in Low Risk Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Estimated intraoperative blood loss
研究概览
简要总结
One hundred forty low risk pregnant women scheduled for elective cesarean delivery were randomized (1:1) into two groups: the intrauterine group (n=70) received 400 μg misoprostol (200 μg at each uterine cornu) after placental delivery, while the rectal group (n=70) received 400 μg misoprostol rectally via urinary catheter insertion preoperatively.
详细描述
Intrauterine Misoprostol Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered intrauterinely after placental delivery during cesarean section. The dose was divided as 200 μg placed at each uterine cornu.
Rectal Misoprostol Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively Standard Care All participants received standard active management of the third stage of labor including: Intravenous bolus of 5 IU oxytocin after fetal delivery 20 IU oxytocin diluted in 500 mL lactated Ringer's solution infused at 125 mL/hour Surgical Protocol All cesarean deliveries were performed under spinal anesthesia using a standardized surgical technique
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Low risk women with singleton living fetus scheduled for elective cesarean delivery
- •American Society of Anesthesiologists (ASA) physical status I or II
- •Age: 20-40 years
- •Parity: 0-3
- •Gestational age: 37-40 completed weeks
- •Body mass index (BMI): 18-30 kg/m²
- •Planned spinal anesthesia
- •Provision of informed consent
排除标准
- •High risk pregnancies (anemia, renal disease, cardiac disease, hepatic disease, coagulopathies)
- •Increased risk for obstetric hemorrhage (placenta previa, placenta accreta spectrum, polyhydramnios, history of PPH, uterine rupture, uterine fibroids)
- •Allergy to prostaglandins or prostaglandin contraindications (e.g., asthma)
- •Complicated cesarean sections (bladder/ureteric injury, intestinal injury, massive intraoperative bleeding)
- •Known fetal or structural anomalies
- •Refusal to participate
结局指标
主要结局
Estimated intraoperative blood loss
时间窗: at time of surgery
Combined blood from suction and soaked materials
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
Professor
Cairo University