The Effect of Pre-operative Versus Post-operative Misoprostol in Reducing Blood Loss During and After Elective Cesarean Section.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Estimation of Intraoperative and postoperative blood loss.
研究概览
简要总结
Cesarean section is the most common performed major surgical interventions among women all over the world.Cesarean section has many serious complications, including primary postpartum hemorrhage (PPH). Postpartum hemorrhage is one of the most serious causes of maternal mortality and morbidity, especially in developing countries, and the number of maternal deaths due to postpartum hemorrhage is estimated to exceed 100,000 maternal deaths each year. The incidence of CS is increasing and the average blood loss during CS (1000 mL) is double the amount lost during vaginal delivery (500 mL) .
The most successful technique for decreasing PPH is active management of the third stage of labor (AMTSL), requires prophylactic utero-tonic drugs as oxytocin, ergometrine malate and combinations of them , They must be administered by injection.
Misoprostol is synthetic prostaglandin (PGE1 analogue), with utero-tonic properties, has been proposed as an alternative strategy for prevention of PPH in settings where oxytocin use is not handy. It has important advantages over oxytocin, including the potential for oral administration and a long shelf life at room temperature.Misoprostol is affordable and widely available, can be easily administered via multiple routes, and has a good safety profile if properly administered and monitored, all of which makes it an alternative treatment option of PPH in developing countries.
Investigators were comparing the effect of preoperative and post-operative rectally administrated misoprostol on operative blood loss at cesarean section. Misoprostol has an important effect in terms of decreased postoperative morbidity and a decrease in risks associated with blood transfusions.
详细描述
History taking:
- Verbal consent.
- Detailed clinical history.
- Personal history:
Name, Age, Parity, Occupation, Residency and Special habits.
-
Present history: History of onset, course and duration of vaginal bleeding or bloody vaginal discharge, presence of uterine contraction, PROM, IUGR or any indication for cesarean section.
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Obstetric history: History of previous preterm labor, previous abortion, previous full term deliveries, RH incompatibility, mode of delivery and fetal outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Women booked for elective cesarean section not in active labor
- •Scheduled for primary elective caesarian section.
- •No contraindications to prostaglandins.
- •Have no history of coagulopathy.
- •Aged between 18-40 years.
- •Full term pregnancies (GA 37 to 42 weeks).
- •Singleton pregnancies.
- •BMI 20-30 kg/ m2
排除标准
- •Placenta previa.
- •Maternal hypertension and Pre-eclampsia. .
- •Diabetes mellitus.
- •Previous CS and those with active labor.
- •Multiple Fibroid uterus .
- •Multiple pregnancies.
- •Overdistended uterus eg. polyhydramnios
- •Previous myomectomy, previous history of PPH .
- •Contraindication to spinal anesthesia.
- •Blood coagulopathy and bleeding disorder.
- •Marked maternal anemia (Preoperative hemoglobin <9 gm/dl).
- •Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol.
- •Extreme of BMI (<20 or >30Kg/m2).
研究组 & 干预措施
preop
60 women: will receive preoperative 600 microgram of misoprostol ( 3 tablets ) rectally after spinal anaesthesia and urinary catheterization and postoperative placebo (3 tablets). (as per WHO dose recommendation)
干预措施: Misoprostol 200mcg Tab (Drug)
postop
60 women: will receive preoperative placebo "3 tablets" and postoperative 600 microgram of misoprostol " 3 tablets" at operating theatre (as per WHO dose recommendation).
干预措施: Misoprostol Pill (Drug)
结局指标
主要结局
Estimation of Intraoperative and postoperative blood loss.
时间窗: 24 hours
calculate total blood loss in guaze and suction bottle
次要结局
- Need of extra utero-tonic drugs(24 hours)
- Incidence of postpartum hemorrhage.(24 hours)
- The incidence of side effects e.g. nausea, vomiting, diarrhea, shivering and headache.(24 hours)
研究者
ahmed nagy shaker ramadan
lecturer
Cairo University
