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Trial registered on ANZCTR


Registration number
ACTRN12618000689279
Ethics application status
Approved
Date submitted
3/04/2018
Date registered
27/04/2018
Date last updated
27/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The benefit of sampling the lactate levels in umbilical cord artery after birth to provide information to doctors and nurses about care in labour and improve future practice.
Scientific title
Introduction of universal cord lactate sampling and correlation with neonatal outcomes in a low resource setting
Secondary ID [1] 294127 0
None
Universal Trial Number (UTN)
U1111-1209-6685
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intrapartum care 306732 0
Condition category
Condition code
Reproductive Health and Childbirth 305831 305831 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All midwives and registrars in the unit underwent a training course in fetal physiology, lactate physiology and cardiotocograph (CTG) interpretation, conducted by the primary researcher (EA). The course consisted of a pre-test, a series of didactic lectures, interactive application of knowledge with CTG examples, and a post-test. The course was an intensive half a day course. The pre-test consisted of 20 multiple choice questions. Then 3 hour long lectures were given; on fetal physiology, fetal acid base status, and CTG pattern recognition. A 36 questionairre post test was then delivered. It was a requirement of the unit that all doctors and midwifes complete the training.

Subsequently umbilical artery lactate sampling occurred, with the results made immediately available to the clinicians managing the intrapartum care of women in the labour ward. Lactate samples were obtained by (after maternal consent was obtained): the umbilical cord was clamped and cut within one minute of birth. A small arterial blood sample (<0.5uL) was then taken from a double clamped segment of the remaining umbilical cord, prior to delivery of the placenta. The lactate level was measured (mmol/L) on a Roche Accutrend PlusTM© hand-held lactate meter (Rotkreuz, Switzerland). The coefficient of variation (CV) for this lactate meter is 1.8-3%. Furthermore, all lactate samples obtained in the previous 24 hours were reviewed at the daily morning labour ward meetings of all medical staff (interns, registrars, and consultants), and twice weekly, an in-depth review of interesting or challenging cases was facilitated by the primary researcher (EA). Daily reviews involved correlating CTG interpretation pre-delivery with neonatal outcomes, including the UA lactate. During the two study periods, basic data on all deliveries (regardless of recruitment to the study) were collected, including number of deliveries, mode of deliveries, and admissions to the neonatal nursery (all levels).
Intervention code [1] 300407 0
Prevention
Comparator / control treatment
This was a before and after study to determine the impact of umbilical artery lactate sampling on maternal and neonatal outcomes.

The study groups included prospectively collected samples of umbilical artery lactate obtained by the primary researcher (EA), or a doctor in the unit trained by the primary researcher. All women aiming to have a vaginal delivery were eligible to be consented for the trial, regardless of their ultimate mode of delivery. The primary researcher (EA) was on the labour ward 7am-5pm daily to train doctors in sampling, observe technique, and ensure fidelity to the intervention. During the period 3rd March to 18th of July 2014, a prospective cohort of women were consented to be enrolled in the trial. The results of the lactate sampling in this cohort were blinded to the clinicians (midwives, registrars, and consultants) managing the intrapartum care of women. This cohort served as the baseline for the unit, the result of which have been published previously
Control group
Active

Outcomes
Primary outcome [1] 305384 0
Need for neonatal resuscitation, as described in the birth registry and the delivery notes (data from medical records)
Timepoint [1] 305384 0
Delivery / immediate neonatal period
Primary outcome [2] 305385 0
Admission to the neonatal nursery as described in the birth registry, the delivery notes, and the nursery admission records (data from medical records)
Timepoint [2] 305385 0
Delivery / immediate neonatal period
Primary outcome [3] 305386 0
Caesarean section rates as calculated from the caesarean section rate (determined from the delivery notes) over the total births during the same time period (determined from the birth registry)
Timepoint [3] 305386 0
Delivery
Secondary outcome [1] 345025 0
Lactate levels over time as assessed by umbilical artery sampling at birth
Timepoint [1] 345025 0
Measured at delivery in each participant, for the duration of trial

Eligibility
Key inclusion criteria
All women attending Kalafong Hospital with a view to a planned vaginal birth. Women will receive routine intrapartum care defined by the institutions policies.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women unable to give consent
- Cases with planned cord blood collection for stem cell banking

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Prospective cohort, therefore no allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Before and after trial:

During the period 3rd March to 18th of July 2014, a prospective cohort of women were consented to be enrolled in the trial. The results of the lactate sampling in this cohort were blinded to the clinicians (midwives, registrars, and consultants) managing the intrapartum care of women. This cohort served as the baseline lactate levels for the unit. Before the completion of the cohort, all midwives and registrars in the unit underwent a training course in fetal physiology, lactate physiology and cardiotocograph (CTG) interpretation, conducted by the primary researcher (EA). The course consisted of a pre-test, a series of didactic lectures, interactive application of knowledge with CTG examples, and a post-test. Subsequently, from 21st July to 12th November 2014, lactate sampling continued, with the results made immediately available to the clinicians managing the intrapartum care of women in the labour ward. Furthermore, all lactate samples obtained in the previous 24 hours were reviewed at the daily morning labour ward meetings of all medical staff (interns, registrars, and consultants), and twice weekly, an in-depth review of interesting or challenging cases was facilitated by the primary researcher (EA). Daily reviews involved correlating CTG interpretation pre-delivery with neonatal outcomes, including the UA lactate. During the two study periods, basic data on all deliveries (regardless of recruitment to the study) were collected, including number of deliveries, mode of deliveries, and admissions to the neonatal nursery (all levels).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The estimation of sample size was performed using standardised normal lactate mean and standard deviation. A sample size of 265 in each of the pre and post intervention groups would achieve an 80% power to detect a difference of 0.25 standard deviations (approximately 8% difference in means) in lactate measurements between groups using a two-sided sample t-test at 5% significance level. This sample size would also achieve at least 80% power to detect an R-squared of 0.05 attributed to one or more independent variable/s while simultaneously adjusting for multiple other relevant covariates with an R-squared of 0.2 in a multiple linear regression analysis. Assuming a 15% attrition rate, the sample size was increased to 305 in each group for a total sample size of 610. ([Power and Sample Size (PASS 2008)]. To assess the lactate results, data were transformed to the natural logarithm to correct normality and summarised as geometric means and 95% confidence intervals (CI).
Linear regression analysis was conducted on the log transformed lactate measurements and presented as estimated mean effects and 95% CI’s. A multivariate analysis on lactate levels, adjusted for primiparity, HIV, fetal problems in pregnancy and preterm birth, was done with lactate measurements log transformed for the analysis. Summary values of estimated mean effects and 95% confidence intervals were back transformed. Outcomes were summarised using means and standard deviations or medians, interquartile ranges and ranges for continuous data and frequency distributions for categorical data. Based on our previously published cohort study, a cut-off for an abnormal lactate was assumed to be 5·45 mmol/L. Univariate comparisons were made using independent t-tests for continuous outcomes and Chi-square or Fisher exact tests for categorical comparisons. Multivariable logistic regression analysis was performed on maternal and neonatal outcomes including fetal distress, cesarean section, resuscitation, Apgar scores and admission to special care nursery. Results were summarised with unadjusted (OR) and adjusted odds ratios (aOR) and 95% CI’s. Analyses of outcomes were adjusted for preterm birth, primiparity, HIV, previous uterine surgery or maternal problems in pregnancy (maternal outcome), and fetal problems during pregnancy (neonatal outcomes). Maternal problems in pregnancy included being an adolescent, having advanced maternal age (>35), anemia, cervical incompetence, eclampsia, gestational diabetes mellitus, HELLP syndrome, hypertension without pre-eclampsia, , maternal medical conditions, no antenatal care, pre-eclampsia, preterm labour, syphilis, thyrotoxicosis, tuberculosis, urinary tract infection, uterine anomaly, or venous thromboembolic event. A pre-planned subgroup analysis was conducted on infants with birth weight less than 2500g compared with greater than or equal to 2500g and neonatal outcomes were assessed. A Bonferroni adjustment was applied such that the significance level for each comparison of pre- and post-intervention groups within birth weight strata was set to 0·025. All tests were two-sided and a p-value less than 0·05 was considered statistically significant for the overall analysis. SPSS statistical software was used in data analysis (version 22·0, Armonk, NY: IBM Corp).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/03/2014
Date of last participant enrolment
Anticipated
Actual
12/11/2014
Date of last data collection
Anticipated
Actual
12/12/2014
Sample size
Target
610
Accrual to date
Final
994
Recruitment outside Australia
Country [1] 10253 0
South Africa
State/province [1] 10253 0
Pretoria

Funding & Sponsors
Funding source category [1] 298764 0
University
Name [1] 298764 0
University of Western Australia
Country [1] 298764 0
Australia
Primary sponsor type
Individual
Name
Dr Emma Allanson
Address
School of Women’s and Infants Health, University of Western Australia, Faculty of Medicine, Dentistry and Health Sciences, Stirling Highway, The University of Western Australia, Crawley, WA, Australia, 6009
Country
Australia
Secondary sponsor category [1] 297948 0
None
Name [1] 297948 0
Address [1] 297948 0
Country [1] 297948 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299703 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 299703 0
Ethics committee country [1] 299703 0
Australia
Date submitted for ethics approval [1] 299703 0
Approval date [1] 299703 0
26/02/2014
Ethics approval number [1] 299703 0
RA/4/1/6581
Ethics committee name [2] 300045 0
University of Pretroria
Ethics committee address [2] 300045 0
Ethics committee country [2] 300045 0
South Africa
Date submitted for ethics approval [2] 300045 0
Approval date [2] 300045 0
10/02/2014
Ethics approval number [2] 300045 0
7/2014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81342 0
Dr Emma Allanson
Address 81342 0
School of Women’s and Infants’ Health (M550) The University of Western Australia
35 Stirling Hwy CRAWLEY WA 6009


Country 81342 0
Australia
Phone 81342 0
+61 432 199 297
Fax 81342 0
Email 81342 0
Emma.allanson@gmail.com
Contact person for public queries
Name 81343 0
Emma Allanson
Address 81343 0
School of Women’s and Infants’ Health (M550) The University of Western Australia
35 Stirling Hwy CRAWLEY WA 6009


Country 81343 0
Australia
Phone 81343 0
+61 432 199 297
Fax 81343 0
Email 81343 0
Emma.allanson@gmail.com
Contact person for scientific queries
Name 81344 0
Emma Allanson
Address 81344 0
School of Women’s and Infants’ Health (M550) The University of Western Australia
35 Stirling Hwy CRAWLEY WA 6009


Country 81344 0
Australia
Phone 81344 0
+61 432 199 297
Fax 81344 0
Email 81344 0
Emma.allanson@gmail.com

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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