Clinical Trials Directory

Trials / Completed

CompletedNCT06807255

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
303 (actual)
Sponsor
Papa Giovanni XXIII Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

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

Timeline

Start date
2023-05-01
Primary completion
2023-09-30
Completion
2023-10-01
First posted
2025-02-04
Last updated
2025-02-07

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06807255. Inclusion in this directory is not an endorsement.