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临床试验/NCT06807255
NCT06807255已完成不适用

Lactate Values During Labour and Their Correlation With Maternal and Foetal Outcome: a Prospective Observational Single-centre Study

Papa Giovanni XXIII Hospital1 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
303
试验地点
1
主要终点
the primary aim of our study was to assess whether elevated lactate values during labour are associated with an increased risk of PPH

研究概览

简要总结

Postpartum haemorrhage (PPH) represents a significant cause of morbidity in the obstetric population, with a mortality rate of 140,000 women per year, and the predominant cause of PPH (70%) is uterine atony.

Consequently, elevated lactate levels during labour could influence maternal and foetal well-being. We decided to assess lactate concentrations during labour in women receiving neuraxial anaesthesia and evaluate the association between high lactate levels and adverse maternal and foetal outcomes.

The secondary aims of the study were to assess lactate levels at different stages of labour and investigate whether increased lactate concentrations could influence neonatal cord pH upon delivery.

详细描述

We conducted a prospective observational single-centre study involving women in active labour receiving neuraxial anaesthesia.

Labour analgesia was placed at the beginning of active labour, whose definition follows the NICE guidelines. The labour analgesia technique consisted of standard epidural puncture or dural puncture epidural; the maintenance of analgesia was through clinician intermittent boluses given on maternal request.

Lactate levels were assessed via a venous blood gas test utilising an IV cannula already placed in the woman's limb upon admission.

These measurements were taken at three different time points, as follows: T0: at the time of diagnosis of the active phase of the first stage of labour, T1: at the beginning of the active phase of the second stage of labour, at the beginning of active pushing, and T2: at the time of the delivery, before placenta expulsion.

Postpartum haemorrhage (PPH) has been defined following the definition of the Royal College of Obstetricians and Gynaecologists as a total blood loss ≥ 500 ml.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •≥ 18 years old
  • •single pregnancy with a gestational age of ≥ 36 weeks
  • •active labour with a cervix dilation of 4 to 6 cm
  • •neuraxial analgesia
  • •consent to the study Exclusion criteria
  • •< 18 years
  • •twin pregnancy
  • •gestational age < 36 weeks,
  • •labour without labour analgesia
  • •cervix dilation > 6 cm at the moment of the placement of neuraxial analgesia
  • •not consent to the study

排除标准

  • 未提供

结局指标

主要结局

the primary aim of our study was to assess whether elevated lactate values during labour are associated with an increased risk of PPH

时间窗: two hours

Postpartum haemorrhage has been defined following the definition of the Royal College of Obstetricians and Gynaecologists as a total blood loss ≥ 500 ml. Our population was divided into two groups: those with total blood loss ≤ 500 ml and those with blood loss \> 500 ml.

次要结局

  • The secondary aims of the study were to assess lactate levels at different stages of labour and investigate whether increased lactate concentrations could influence neonatal cord pH upon delivery(Time of labour)
  • neonatal cord pH upon delivery(five minutes)

研究者

发起方
Papa Giovanni XXIII Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Barbara Milan

MD

Papa Giovanni XXIII Hospital

研究点 (1)

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