Clinical trial NCT06807255: Lactate Values During Labour and Their Correlation With Maternal and Foetal Outcome
Official title: Lactate Values During Labour and Their Correlation With Maternal and Foetal Outcome: a Prospective Observational Single-centre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactate Values During Labour in Women Receiving Neuraxial Anaesthesia
Keywords: Lactate values during labour,
maternal and foetal outcome
HIFI
myometrial contraction
lactacidemia
Lead sponsor: Papa Giovanni XXIII Hospital
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 303
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women in active labour receiving neuraxial anaesthesia

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: the primary aim of our study was to assess whether elevated lactate values during labour are associated with an increased risk of PPH
timeFrame: two hours
Secondary outcomes:
measure: 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
timeFrame: Time of labour
measure: neonatal cord pH upon delivery
timeFrame: five minutes
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
Study officials:
affiliation: ASST Papa Giovanni XXIII
name: Giulia Fierro, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.