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临床试验/NCT03578263
NCT03578263已完成不适用

Carbetocin Versus Oxytocin and Ergometrine for Prevention of Postpartum Hemorrhage Following a Cesarean Section in Women With Multiple Gestation

Aswan University Hospital1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2018年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
220
试验地点
1
主要终点
estimation of intraoperative blood loss (ml).

研究概览

简要总结

The cesarean section is a bloody operation, about 750 to 1000 ml are lost at most operations and over 1000 ml of blood have lost to bring them into the definition of a postpartum hemorrhage (PPH). In developing countries, PPH is the main cause of maternal deaths. Uterine atony is the most common cause of immediate heavy PPH.Multiple pregnancy ones of a common factor for uterine atony. The administration of oxytocic's after the delivery of the neonate reduces the likelihood of PPH and 5 IU oxytocin by slow intravenous injection is currently recommended for all cesarean sections. However, the use of additional oxytocic medication is common, to arrest bleeding, or prophylactically if there are risk factors for PPH . Carbetocin is a synthetic analog of human oxytocin with structural modifications that increase its half-life, thereby prolonging its pharmacological effects. Carbetocin has been approved in 23 countries for prevention of uterine atony and excessive bleeding following cesarean delivery in spinal or epidural anesthesia. Oxytocin is a peptide of nine amino acids (Nona peptide). The structure of oxytocin is very similar to that of arginine vasopressin, whose sequence differs from oxytocin by 2 amino acids. The best-known mechanism for oxytocin to exert its stimulatory effect on myometrial contractility is by increasing the intracellular concentration of calcium. Owing to its short plasma half-life (mean 3 min), a continuous intravenous infusion is required to maintain the uterus in a contracted state. The usual dose is 20 IU in 500 ml of crystalloid solution, with the dosage rate adjusted according to response. Ergometrine is a selective and moderately potent tryptaminergic receptor antagonist in various smooth muscles, being only a partially agonistic or antagonistic at tryptaminergic receptors in the central nervous system. In blood vessels, the alkaloid is only weakly antagonistic of dopaminergic receptors and partially agonistic of α-adrenergic receptors. oxytocin (19%). Blood loss>500 ml was only observed in women who received oxytocin. The aim of the investigator's study was to compare the effect of carbetocin vs. oxytocin and ergometrine for prevention of PPH during cesarean section in women with multiple pregnancies.

详细描述

Women included in the study were divided into 2 groups: Group (A): included patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby. Group (B): included patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and intramuscular ergometrine 0.2 mg. The slow administration has been shown to reduce the potentially harmful hemodynamic effects of oxytocin (and presumably carbetocin). Also, intramuscular injection of ergometrine did the same. All women were subjected to full history taking, general and obstetric examination and investigations in the form of preoperative routine labs and obstetric ultrasound, and postoperative serum hemoglobin %.

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 (Participant)

盲法说明

the participants blinded the arms of the study

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • women with a multiple term pregnancy undergoing elective cesarean section

排除标准

  • single gestation
  • placenta praevia and placental abruption
  • undergoing cesarean section with general anesthesia
  • women undergoing cesarean section at less than 37 weeks of gestation
  • with a severe medical disorder

研究组 & 干预措施

carbetocin arm

Experimental

carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby

干预措施: Carbetocin (Drug)

oxytocin and ergometrine arm

Active Comparator

oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist plus intramuscular ergometrine 0.2 mg after the birth of the baby

干预措施: oxytocin (Drug)

oxytocin and ergometrine arm

Active Comparator

oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist plus intramuscular ergometrine 0.2 mg after the birth of the baby

干预措施: ergometrine (Drug)

结局指标

主要结局

estimation of intraoperative blood loss (ml).

时间窗: intraoperative

Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding

次要结局

  • need for blood transfusion(24 hours postoperative)
  • Hemoglobin concentration(ist 24 hours postoperative])

研究者

发起方
Aswan University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

hany farouk

lecturer

Aswan University Hospital

研究点 (1)

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