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临床试验/NCT04201665
NCT04201665已完成不适用

Uterine Electromyography for Estimation of Uterotonic Efficiency for Postpartum Hemorrhage Prevention

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月13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
入组人数
60
试验地点
1
主要终点
Power density spectrum peak frequency of uterine EMG bursts

研究概览

简要总结

Studies found conflicting results on efficacy of uterotonic agents used to prevent and treat uterine atony, the most common cause of postpartum hemorrhage. Uterine EMG can be used to objectively assess myometrial contractility and, consequently, efficacy of different uterotonics.

The investigators are planning a single-center, randomized, open-label trial to compare uterine EMG parameters in women receiving oxytocin vs. those receiving carbetocin after cesarean delivery.

详细描述

RATIONALE

Postpartum hemorrhage is the leading cause of maternal mortality worldwide. In the Western world the estimated risk of life threatening postpartum hemorrhage is 2 on 1000 births. Most frequently (up to 90% of cases of postpartum hemorrhage) it is a consequence of uterine atony or inappropriate uterine contraction. In clinical practice preventing postpartum hemorrhage is key and routinely, different prophylactic uterotonic drugs are used. The first-line recommended drug for postpartum hemorrhage prevention is oxytocin. However, a recent Cochrane meta-analysis concluded that the most effective drugs (compared to oxytocin) to prevent postpartum hemorrhage of 500 ml or more are ergometrine with oxytocin, misoprostol with oxytocin and carbetocin.

Carbetocin is a synthetic heat-stable analogue of oxytocin, with a longer half-life. It shares the same mechanism of action and the same side-effects as oxytocin. The recommended dose of carbetocin is 100 μg, which is equivalent to 10 μg (5 IU) of oxytocin. In the WHO carbetocin multicenter, double-blind, randomized trial, the intramuscular administration of 100 μg of heat-stable carbetocin was discovered to be noninferior to the administration of 10 IU of oxytocin for the prevention of postpartum hemorrhage after vaginal birth. Some studies have found carbetocin to be an effective prophylactic agent with a favourable side effect profile for the third stage of labour in caesarean sections, reducing the use of additional uterotonic agents, blood and recovery time. Moreover, carbetocin was found to be effective in reducing the need for additional uterotonic use and postpartum blood transfusion in women at increased risk of postpartum hemorrhage undergoing cesarean delivery. In one study, carbetocin was also found to be more effective than oxytocin in preventing postpartum hemorrhage in twin pregnancies delivered by cesarean section.

Uterine contractions in pregnancy, labour and postpartum can be detected using electromyography. Myometrial contractility can be objectively and non-invasively assessed in vivo by monitoring uterine electromyography (EMG), as uterine contractions are the result of the electrical activity generated and propagated in the myometrium.

To our knowledge, no study has reported oxytocin or carbetocin effects using postpartum electromyography.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with singleton pregnancies at term ( ≥37 weeks of pregnancy) scheduled for elective cesarean section after one previous cesarean section.

排除标准

  • Contraindications for any of the study drugs.
  • Anaemia Hb <100g
  • History of postpartum hemorrhage
  • Uterine fibroids
  • Blood clotting disorder
  • Placental disorder ( Placenta previa, placenta accreta)
  • Preeclampsia
  • Renal, cardiac or hepatic dysfunction.

研究组 & 干预措施

carbetocin

Experimental

Patients will receive a single dose of carbetocin 100 mcg (Pabal ®) at admission to high dependency obstetric unit after cesarean section.

干预措施: Carbetocin (Drug)

oxytocin

Active Comparator

Patients will receive 5 units of oxytocin ( Syntocinon ®) as a 250 ml 0.9% NaCl infusion at admission to high dependency obstetric unit after cesarean section.

干预措施: Oxytocin (Drug)

结局指标

主要结局

Power density spectrum peak frequency of uterine EMG bursts

时间窗: within 3 hours from starting treatments

Change in Power density spectrum (PDS) peak frequency of uterine EMG bursts between EMG at admission and 2-3 hours after treatment

次要结局

  • Frequency and duration of uterine EMG bursts(within 3 hours from starting treatments)
  • Power density spectrum integral of uterine EMG bursts(within 3 hours from starting treatments)
  • Propagation velocity of uterine EMG signals(within 3 hours from starting treatments)
  • Quantified blood loss(within 3 hours from starting treatments)
  • Change in hematocrit(within 24 hours after delivery)
  • Power density spectrum peak amplitude of uterine EMG bursts(within 3 hours from starting treatments)
  • Change in hemoglobin(within 24 hours after delivery)

研究者

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

Miha Lucovnik

assistant professor

University Medical Centre Ljubljana

研究点 (1)

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