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Trial registered on ANZCTR


Registration number
ACTRN12611000172909
Ethics application status
Approved
Date submitted
1/02/2011
Date registered
15/02/2011
Date last updated
19/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Fetal lactate measurement to reduce caesarean sections during labour: a randomised trial
Scientific title
Non-reassuring fetal status assessed by the addition of lactate measurement, compared with fetal heart rate by cardiotocography-only, to reduce caesarean section rates.
Secondary ID [1] 253523 0
Nil
Universal Trial Number (UTN)
U1111-1119-2619
Trial acronym
Flamingo
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Caesarean section 261074 0
Non-reassuring fetal status 261147 0
Condition category
Condition code
Public Health 259221 259221 0 0
Other public health
Reproductive Health and Childbirth 259304 259304 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 259305 259305 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Addition of fetal blood sampling for lactate measurement during labour to standard monitoring of the fetal heart rate by cardiotocography.

The initial sample will be taken following study enrollment. If non-reassuring cardiotocograph persists, repeat samples will be taken at 30-60 minute intervals until birth.
Intervention code [1] 257952 0
Diagnosis / Prognosis
Comparator / control treatment
Standard monitoring of the fetal heart rate by cardiotocography only
Control group
Active

Outcomes
Primary outcome [1] 262056 0
Caesarean section following the initiation of labour
Timepoint [1] 262056 0
Time of birth
Secondary outcome [1] 273065 0
Total operative birth (forceps + vacuum + caesarean section)
Timepoint [1] 273065 0
Birth
Secondary outcome [2] 273171 0
Total operative vaginal birth (forceps + vacuum)
Timepoint [2] 273171 0
Birth
Secondary outcome [3] 273172 0
Normal vaginal birth
Timepoint [3] 273172 0
Birth
Secondary outcome [4] 273173 0
Caesarean section specifically for the indication of non-reassuring fetal status
Timepoint [4] 273173 0
Birth
Secondary outcome [5] 273174 0
Assisted vaginal birth (forceps or vacuum) for non-reassuring fetal status
Timepoint [5] 273174 0
Birth
Secondary outcome [6] 273175 0
Maternal satisfaction with fetal monitoring in labour: assessed by survey, modified for this trial from survey used by East et al, BIRTH, 33:2, 2006.
Timepoint [6] 273175 0
Birth to hospital discharge
Secondary outcome [7] 273176 0
Maternal length of hospital stay
Timepoint [7] 273176 0
Birth to hospital discharge
Secondary outcome [8] 273177 0
Composite fetal/neonatal endpoint: Death or serious outcome for the infant: includes one or more of fetal death after trial entry; death of a liveborn infant prior to hospital discharge; Apgar score <4 at 5 minutes; seizures at <24hours of age or requiring two or more drugs to control; neonatal encephalopathy (stages II / III); care in neonatal intensive care unit >4 days.
Timepoint [8] 273177 0
Birth to hospital discharge
Secondary outcome [9] 273179 0
Individual components of the composite fetal/neonatal endpoint
Timepoint [9] 273179 0
Birth to hospital discharge
Secondary outcome [10] 273180 0
Neonatal encephalopathy (stages I, II, III)
Timepoint [10] 273180 0
Birth to hospital discharge
Secondary outcome [11] 273181 0
Apgar score <7 at 5 minutes
Timepoint [11] 273181 0
Birth to 5 minutes of age
Secondary outcome [12] 273182 0
Umbilical cord arterial and venous blood gases (pH, base deficit and lactate)
Timepoint [12] 273182 0
Sampled within few minutes of birth
Secondary outcome [13] 273183 0
Neonatal resuscitation (bag and mask ventilation, intubation, external cardiac massage and/or adrenaline)
Timepoint [13] 273183 0
Birth to 20 minutes
Secondary outcome [14] 273184 0
Neonatal length of hospital stay
Timepoint [14] 273184 0
Birth to hospital discharge
Secondary outcome [15] 273185 0
Economic analysis (cost-effectiveness) of fetal monitoring: costs of treatment-related expenses, incorporating diagnosis-related group costs and direct costs.
Timepoint [15] 273185 0
Labour/birth to hospital discharge

Eligibility
Key inclusion criteria
Greater than or equal to 37 weeks gestation
Labour
Non-reassuring fetal heart rate pattern
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindication to fetal scalp blood sampling, including known HIV and Hepatitis B or C
Planned caesarean section
Chorioamnionitis requiring urgent delivery
Known significant fetal anomaly

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opt-in consent in use throughout trial.
April 2014, the Royal Women's Hospital Human Research Ethics Committee approved the use of the opt-out approach for consent, with women provided with information at least twice during their pregnancy and asked to advise of their wish to opt-out.
Following consent, randomisation occurs by sequentially numbered, sealed, opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher not otherwise involved with the trial will use computerised sequence generation, with permuted block randomisation, stratified for parity (nulliparous, parous).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3335 0
The Royal Women's Hospital - Parkville

Funding & Sponsors
Funding source category [1] 258414 0
Government body
Name [1] 258414 0
NHMRC Project Grant
Address [1] 258414 0
16 Marcus Clarke Street Canberra ACT 2601 Australia
Country [1] 258414 0
Australia
Primary sponsor type
Individual
Name
Prof Christine East
Address
Royal Women's Hospital
20 Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 257565 0
None
Name [1] 257565 0
Address [1] 257565 0
Country [1] 257565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260388 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 260388 0
20 Flemington Rd
Parkville VIC 3052
Ethics committee country [1] 260388 0
Australia
Date submitted for ethics approval [1] 260388 0
31/07/2011
Approval date [1] 260388 0
06/12/2011
Ethics approval number [1] 260388 0

Summary
Brief summary
There is currently an epidemic of caesarean sections performed in Australia and overseas. Although many caesarean sections are performed for concerns about fetal welfare, the majority of babies are shown to be well at birth, meaning that the operation, with its inherent short- and long-term risks, could have been avoided, without compromising the baby’s health. In this study, half the babies with a non-reassuring heart rate recording during labour will have a blood test to measure lactate and the other half will not. We will then determine whether having a lactate test makes a difference in the number women having caesarean births.
Trial website
Trial related presentations / publications
Published Protocol
East CE, Kane SV, Davey M-A, Kamlin CO, Brennecke SP. Protocol for a randomised controlled trial of fetal scalp blood lactate measurement to reduce caesarean sections during labour: the Flamingo trial. BMC Pregnancy and Childbirth 2015, 15:285. DOI: 10.1186/s12884-015-0709-7

Updated Cochrane systematic review
East CE, Leader LR, Sheehan P, Henshall NE, Colditz PB, Lau R. Intrapartum fetal scalp lactate sampling for fetal assessment in the presence of a non-reassuring fetal heart rate trace. Cochrane Database of Systematic Reviews 2015, Issue 5. Art. No.: CD006174.DOI: 10.1002/14651858.CD006174.pub3
Public notes

Contacts
Principal investigator
Name 32156 0
Prof Prof Christine East
Address 32156 0
c/- Department of Obstetrics and Gynaecology
Royal Women's Hospital
20 Flemington Rd
Parkville VIC 3052
Australia
Country 32156 0
Australia
Phone 32156 0
+61 409063495
Fax 32156 0
Email 32156 0
christine.east@monash.edu
Contact person for public queries
Name 15403 0
Prof Christine East
Address 15403 0
Royal Women's Hospital
20 Flemington Rd
Parkville VIC 3052
Country 15403 0
Australia
Phone 15403 0
+61 3 8345 3726
Fax 15403 0
+61 3 8345 3702
Email 15403 0
flamingo@thewomens.org.au
Contact person for scientific queries
Name 6331 0
Prof Christine East
Address 6331 0
Royal Women's Hospital
20 Flemington Rd
Parkville VIC 3052
Country 6331 0
Australia
Phone 6331 0
+61 3 8345 3726
Fax 6331 0
+61 3 8345 3702
Email 6331 0
flamingo@thewomens.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary