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Completed

NCT Number: NCT06807255

Lactate Values During Labour and Their Correlation With Maternal and Foetal Outcome

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

ASST Papa Giovanni XXIII

Bergamo, 24129, Italy

About this study

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.

To measure umbilical cord pH, 1-2 ml of cord blood were taken from the umbilical artery one minute after birth, regardless of clamping.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 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

Treatment and study plan

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

Diagnostic Test

Lactate levels were assessed via a venous blood gas test utilising an IV cannula already placed in the woman's limb upon admission; subsequent analysis was conducted using rapid processing (under 5 minutes from the pre-test) with the Rapidpoint 500 Systems-Siemens (Siemens, Milano) emogasanalyzer

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. 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 frame: Time of labour

    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.

  2. neonatal cord pH upon delivery

    Time frame: five minutes

    To measure umbilical cord pH, 1-2 ml of cord blood were taken from the umbilical artery one minute after birth, regardless of clamping.

Sponsors and collaborators

Lead sponsor

Papa Giovanni XXIII Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 4, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.