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Clinical Trials/NCT06807255
NCT06807255CompletedNot Applicable

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

Papa Giovanni XXIII Hospital1 site in 1 country303 target enrollmentStarted: May 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
303
Locations
1
Primary Endpoint
the primary aim of our study was to assess whether elevated lactate values during labour are associated with an increased risk of PPH

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor
Papa Giovanni XXIII Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Barbara Milan

MD

Papa Giovanni XXIII Hospital

Study Sites (1)

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