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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour

NCT06886555

Labour Analgesia, Epidural Anaesthesia Duration of Labour Labor, Induced

COMPLETED

Prevention of Post-partum Haemorrhage

NCT01044082

Postpartum Haemorrhage Immediate Postpartum Hemorrhage

COMPLETED NA

Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping

NCT04459442

Hematocrit Anemia Acidosis

UNKNOWN NA

Intraumbilical Oxytocin Versus Placental Cord Drainage in the Management of 3rd Stage of Labor

NCT03395730

Postpartum Haemorrhage With Retained Placenta

UNKNOWN PHASE2

Management of the Third Stage of Labor

NCT02319707

Postpartum Hemorrhage

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lactate Values During Labour in Women Receiving Neuraxial Anaesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No