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

NCT06807255 | Completed

• 1 other identifier: REF: no. 751/2023, reg56/23
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Lactate Values During Labour in Women Receiving Neuraxial Anaesthesia

Keywords

Lactate values during labour,; maternal and foetal outcome; HIFI; myometrial contraction; lactacidemia

Outcome Measures

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

  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 Outcomes (2)

• 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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women in active labour receiving neuraxial anaesthesia

You may qualify if:

• ≥ 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

ASST Papa Giovanni XXIII

Bergamo, 24129, Italy

Location

Related Publications (3)

• 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.

  PMID: 27981719 BACKGROUND

• 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.

  PMID: 26195731 BACKGROUND

• 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.

  PMID: 26223765 BACKGROUND

Study Officials

• Giulia Fierro, MD

  ASST Papa Giovanni XXIII

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: May 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 1, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 29/01/2025 for ten years
• Access Criteria: If requested by the reviewer, it will be possible to share the anonymised database

Locations

IT (1)