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临床试验/NCT02303418
NCT02303418Unknown3 期

Carbetocin Versus Oxytocin in the Prevention of Post Partum Haemorrhage (PPH) in Women Undergoing Caesarean Sections for Placenta Previa: A Randomised Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
500
试验地点
2
主要终点
Need for other uterotonic drugs

研究概览

简要总结

The study aims at comparing the roles of carbetocin and oxytocin in the prevention of atonic PPH in women undergoing CS for placenta previa.

200 women will be randomly divided into 2 equal groups using computer generated random numbers, Group 1 will receive Carbetocin 100 µgm (Pabal® Ferring, UK) and group 2 will receive oxytocin 5IU (Syntocinon®, Novartis, Switzerland).

详细描述

Obstetric haemorrhage remains one of the major causes of maternal death in both developed and developing countries. Postpartum haemorrhage (PPH) is defined as a blood loss >500 ml more of blood from the genital tract within 24 hours of the birth of a baby. PPH can be minor (500-1000 ml) or major (more than 1000 ml) . The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases.

Risk factors of atonic PPH include multiple pregnancy, placenta previa, previous PPH, body mass index (BMI) >30, prolonged labour, fetal macrosomia>4kg and primipara> 40 years.

Placenta praevia exists when the placenta is inserted wholly or in part into the lower segment of the uterus. It is classified by ultrasound imaging according to what is relevant clinically: if the placenta lies over the internal cervical os, it is considered a major praevia; if the leading edge of the placenta is in the lower uterine segment but not covering the cervical os, minor or partial praevia exists.

Oxytocin is currently the uterotonic of first choice. It has proven to decrease the incidence of PPH by 40 % and has a rapid onset of action and a good safety profile. A disadvantage of oxytocin is its short half-life of 4-10 min, regularly requiring a continuous intravenous infusion or repeated intramuscular injections.

Carbetocin is a long-acting oxytocin analogue indicated for the prevention of uterine atony after child birth by cesarean section (CS) under epidural or spinal anaesthesia. Carbetocin has a rapid onset of action (within 1-2 min) and a prolonged duration of action (approximately 1 h) because of sustained uterine response with contractions of higher amplitude and frequency. Its safety profile is comparable to that of oxytocin.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Women undergoing CS for placenta previa

排除标准

  • Gestational age <37 weeks
  • Hypertension
  • Preeclampsia
  • Cardiac, renal or liver diseases
  • Need for general anaesthesia
  • Known hypersensitivity to carbetocin
  • Suspected placenta accreta

研究组 & 干预措施

Carbetocin

Active Comparator

100 µgm of Carbetocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug.

干预措施: Carbetocin (Drug)

Oxytocin

Active Comparator

5 mg of oxytocin will be diluted in 10ml saline and will be given by the anesthesist slowly intravenously after delivery of the baby. The uterine tone and amount of bleeding will be noted and the need for further uterotonic agents will be determined 2 minutes after giving the drug.

干预措施: Oxytocin (Drug)

结局指标

主要结局

Need for other uterotonic drugs

时间窗: 2 minutes after giving the drug

If the uterus is not contracted 2 minutes after giving the drug, further uterotonic drugs will be given.

次要结局

  • Development of PPH(2 minutes after giving the drug.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Cairo University

研究点 (2)

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