Lactate Values During Labour in Women Receiving Neuraxial AnaesthesiaNCT06807255
Lactate Values During Labour and Their Correlation With Maternal and Foetal Outcome
An observational study of Lactate Values During Labour in Women Receiving Neuraxial Anaesthesia, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lactate Values During Labour in Women Receiving Neuraxial Anaesthesia
- What is being tested?
- Lactate levels were assessed via a venous blood gas test utilising an IV cannula already placed in the woman's limb upon admission
- Type of treatment
- Injection or infusion
- How many people
- 303 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women in active labour receiving neuraxial anaesthesia
Who may be able to join
- ≥ 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Lactate levels were assessed via a venous blood gas test utilising an IV cannula already placed in the woman's limb upon admission
- Keywords
- Lactate values during labour,, maternal and foetal outcome, HIFI, myometrial contraction, lactacidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactate levels were assessed via a venous blood gas test utilising an IV cannula already placed in the woman's limb upon admissionDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 May 2023
- Primary completion30 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lactate Values During Labour in Women Receiving Neuraxial AnaesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papa Giovanni XXIII Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Milan, Papa Giovanni XXIII Hospital
- Investigators
- Giulia Fierro, MD, Study chair, ASST Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807255
- Sponsor's protocol ID
- REF: no. 751/2023, reg56/23
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested by the reviewer, it will be possible to share the anonymised database
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.
PubMed 27981719Alotaibi 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.
PubMed 26195731Hanley 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.
PubMed 26223765
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactate Values During Labour and Their Correlation With Maternal and Foetal Outcome: a Prospective Observational Single-centre Study
- ClinicalTrials.gov ID
- NCT06807255
- Acronym / sponsor ID
- REF: no. 751/2023, reg56/23
- Keywords
- Lactate values during labour,, maternal and foetal outcome, HIFI, myometrial contraction, lactacidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Papa Giovanni XXIII HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women in active labour receiving neuraxial anaesthesia
Key inclusion criteria (11 listed)
- ≥ 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactate 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 | Diagnostic test | – |
Primary outcome
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.
2 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 frame: Time of labour
neonatal cord pH upon delivery
Time frame: five minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Background: PubMed 27981719Prevention 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.
- Background: PubMed 26195731Alotaibi 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.
- Background: PubMed 26223765Hanley 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.
- Individual participant dataSharing planned: Yes. If requested by the reviewer, it will be possible to share the anonymised database
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giulia Fierro, MD study chair
ASST Papa Giovanni XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lactate Values During Labour in Women Receiving Neuraxial Anaesthesia, run by Papa Giovanni XXIII Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06807255, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.