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

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.

Study Overview

• Status: Completed
• Conditions: Lactate Values During Labour in Women Receiving Neuraxial Anaesthesia
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

• Italy
  • Bergamo, Italy, 24129
    • ASST Papa Giovanni XXIII

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

women in active labour receiving neuraxial anaesthesia

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the primary aim of our study was to assess whether elevated lactate values during labour are associated with an increased risk of PPH	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.	two hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Time of labour
neonatal cord pH upon delivery	To measure umbilical cord pH, 1-2 ml of cord blood were taken from the umbilical artery one minute after birth, regardless of clamping.	five minutes

Collaborators and Investigators

• Sponsor: Papa Giovanni XXIII Hospital
• Investigators: Study Chair: Giulia Fierro, MD, ASST Papa Giovanni XXIII

Publications and helpful links

General Publications

• Prevention and Management of Postpartum Haemorrhage: Green-top Guideline No. 52. BJOG. 2017 Apr;124(5):e106-e149. doi: 10.1111/1471-0528.14178. Epub 2016 Dec 16. No abstract available.
• Hanley JA, Weeks A, Wray S. Physiological increases in lactate inhibit intracellular calcium transients, acidify myocytes and decrease force in term pregnant rat myometrium. J Physiol. 2015 Oct 15;593(20):4603-14. doi: 10.1113/JP270631. Epub 2015 Sep 3.
• Alotaibi M, Arrowsmith S, Wray S. Hypoxia-induced force increase (HIFI) is a novel mechanism underlying the strengthening of labor contractions, produced by hypoxic stresses. Proc Natl Acad Sci U S A. 2015 Aug 4;112(31):9763-8. doi: 10.1073/pnas.1503497112. Epub 2015 Jul 20.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Lactate values during labour,; maternal and foetal outcome; HIFI; myometrial contraction; lactacidemia
• Other Study ID Numbers: REF: no. 751/2023, reg56/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If requested by the reviewer, it will be possible to share the anonymised database
• IPD Sharing Time Frame: 29/01/2025 for ten years
• IPD Sharing Access Criteria: If requested by the reviewer, it will be possible to share the anonymised database
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No