Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12616001009404
Ethics application status
Approved
Date submitted
13/07/2016
Date registered
1/08/2016
Date last updated
14/11/2018
Date data sharing statement initially provided
14/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
The utility of predicting intrapartum fetal compromise at term using fetal cerebro-umbilical ratio and maternal placental growth factor
Query!
Scientific title
Predicting intrapartum fetal compromise at term using the fetal cerebro-umbilical ratio and placental growth factor (PROMISE Study)
Query!
Secondary ID [1]
288877
0
None
Query!
Universal Trial Number (UTN)
U1111-1181-3852
Query!
Trial acronym
PROMISE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
fetal compromise
298176
0
Query!
Condition category
Condition code
Reproductive Health and Childbirth
298337
298337
0
0
Query!
Fetal medicine and complications of pregnancy
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Screening test at 37 weeks gestation for fetal compromise consisting of:
- maternal placental growth factor blood test (PlGF) (single blood test, collected by phlebotomist or doctor, collected at pathology service or antenatal clinic setting); and
- ultrasound scan of fetal dopplers, specifically the cerebro-umbilical ratio (CUR) (single USS of approximately 45mins duration, performed in antenatal clinic setting by qualified sonographer or obstetric doctor).
A screen positive test result is defined as a CUR of <= 1.27 AND PlGF level <= 81 pg/ml.
For participants who screen 'positive' (increased risk of fetal distress) obstetrician to recommend induction of labour within 7 days (induction will be undertaken by qualified midwife or resident/registrar/consultant, will occur in antenatal ward and birthing suite).
Query!
Intervention code [1]
294369
0
Early detection / Screening
Query!
Comparator / control treatment
Normal antenatal care - no screening test. Normal antenatal care is provided as per the RANZCOG guidelines and internal policies and procedures of the hospital. It can vary depending on the individual patient characteristics but usually involves multidisciplinary care from midwives and doctors.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
297857
0
Composite outcome of:
- emergency caesarean section for fetal compromise, or
- severe adverse neonatal outcomes (cord arterial pH <7.1 and/or Lactate >6 mmol.L or base excess >12 or Apgar score <5 at 5 minutes), or
- fetal/neonatal death.
Query!
Assessment method [1]
297857
0
Query!
Timepoint [1]
297857
0
Within 28 days of delivery of baby as this encompasses the entire neonatal period.
Query!
Secondary outcome [1]
322467
0
Incidence of birth weight <3rd centile or >97th centile - assessed by review of neonatal/birth record.
Query!
Assessment method [1]
322467
0
Query!
Timepoint [1]
322467
0
Within 28 days of delivery of baby as this encompasses the entire neonatal period and is a reasonable timeframe for determining maternal complications.
Query!
Secondary outcome [2]
326125
0
Pathological UA dopplers (absent or reversed end diastolic flow) - assessed by review of antenatal USS records
Query!
Assessment method [2]
326125
0
Query!
Timepoint [2]
326125
0
Within 28 days of delivery of baby
Query!
Secondary outcome [3]
326126
0
Non-cephalic presentation - assessed by review of birth record and antenatal USS record
Query!
Assessment method [3]
326126
0
Query!
Timepoint [3]
326126
0
Within 28 days of delivery of baby
Query!
Secondary outcome [4]
326127
0
Intrapartum CTG abnormalities (suspicious/pathological fetal heart rate patterns) - assessed by review of Guardian record and birth record.
Query!
Assessment method [4]
326127
0
Query!
Timepoint [4]
326127
0
Within 28 days of delivery of baby
Query!
Secondary outcome [5]
326128
0
Meconium aspiration - assessed by review of neonatal record
Query!
Assessment method [5]
326128
0
Query!
Timepoint [5]
326128
0
Within 28 days of delivery of baby
Query!
Secondary outcome [6]
326129
0
Necrotizing enterocolitis - assessed by review of neonatal record
Query!
Assessment method [6]
326129
0
Query!
Timepoint [6]
326129
0
Within 28 days of delivery of baby
Query!
Secondary outcome [7]
326130
0
Neonatal hypoglycemia requiring intravenous glucose - assessed by review of neonatal record
Query!
Assessment method [7]
326130
0
Query!
Timepoint [7]
326130
0
Within 28 days of delivery of baby
Query!
Secondary outcome [8]
326131
0
Length of stay in SCN or NICU - assessed by review of neonatal record
Query!
Assessment method [8]
326131
0
Query!
Timepoint [8]
326131
0
Within 28 days of delivery of baby
Query!
Secondary outcome [9]
326132
0
Neonatal seizures - assessed by review of neonatal record
Query!
Assessment method [9]
326132
0
Query!
Timepoint [9]
326132
0
Within 28 days of delivery of baby
Query!
Secondary outcome [10]
326133
0
Neonatal encephalopathy - assessed by review of neonatal record
Query!
Assessment method [10]
326133
0
Query!
Timepoint [10]
326133
0
Within 28 days of delivery of baby
Query!
Secondary outcome [11]
326134
0
Neonatal death - assessed by review of neonatal record
Query!
Assessment method [11]
326134
0
Query!
Timepoint [11]
326134
0
Within 28 days of delivery of baby
Query!
Secondary outcome [12]
326135
0
Operative intervention (other than caesarean section) for intrapartum fetal compromise - assessed by review of labour/delivery record.
Query!
Assessment method [12]
326135
0
Query!
Timepoint [12]
326135
0
Within 28 days of delivery of baby
Query!
Secondary outcome [13]
326136
0
Intrapartum fetal blood sampling rates - assessed by review of labour/delivery record
Query!
Assessment method [13]
326136
0
Query!
Timepoint [13]
326136
0
Within 28 days of delivery of baby
Query!
Secondary outcome [14]
326137
0
Decision to birth time for operative deliveries - assessed by review of labour/delivery record
Query!
Assessment method [14]
326137
0
Query!
Timepoint [14]
326137
0
Within 28 days of delivery of baby
Query!
Secondary outcome [15]
326138
0
Maternal length of stay in hospital - assessed by review of medical record
Query!
Assessment method [15]
326138
0
Query!
Timepoint [15]
326138
0
Within 28 days of delivery of baby
Query!
Secondary outcome [16]
326139
0
Maternal admission to ICU - assessed by review of medical record
Query!
Assessment method [16]
326139
0
Query!
Timepoint [16]
326139
0
Within 28 days of delivery of baby
Query!
Secondary outcome [17]
326140
0
Maternal sepsis - assessed by review of medical record
Query!
Assessment method [17]
326140
0
Query!
Timepoint [17]
326140
0
Within 28 days of delivery of baby
Query!
Secondary outcome [18]
326141
0
Maternal deep vein thrombosis/pulmonary embolism - assessed by review of medical record
Query!
Assessment method [18]
326141
0
Query!
Timepoint [18]
326141
0
Within 28 days of delivery of baby
Query!
Secondary outcome [19]
326142
0
Other operative complications - assessed by review of medical record
Query!
Assessment method [19]
326142
0
Query!
Timepoint [19]
326142
0
Within 28 days of delivery of baby
Query!
Eligibility
Key inclusion criteria
Singleton pregnancy, with cephalic presentation, planning a vaginal birth.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
45
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Multiple pregnancy, maternal BMI>40, known fetal anomaly or growth restriction, previous caesarean section, known rupture of membranes, pathological umbilical artery dopplers.
Query!
Study design
Purpose of the study
Diagnosis
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/09/2016
Query!
Actual
14/03/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
500
Query!
Accrual to date
450
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
5539
0
Mater Mother's Hospital - South Brisbane
Query!
Recruitment postcode(s) [1]
13005
0
4101 - South Brisbane
Query!
Funding & Sponsors
Funding source category [1]
293258
0
Charities/Societies/Foundations
Query!
Name [1]
293258
0
Mater Foundation
Query!
Address [1]
293258
0
Raymond Terrace, South Brisbane, QLD 4101
Query!
Country [1]
293258
0
Australia
Query!
Primary sponsor type
Hospital
Query!
Name
Mater Health Services
Query!
Address
Raymond Terrace, South Brisbane, QLD 4101
Query!
Country
Australia
Query!
Secondary sponsor category [1]
292062
0
None
Query!
Name [1]
292062
0
Query!
Address [1]
292062
0
Query!
Country [1]
292062
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
294738
0
Mater Human Research Ethics Committee
Query!
Ethics committee address [1]
294738
0
Mater Medical Research Institute Raymond Terrace, South Brisbane, QLD 4101
Query!
Ethics committee country [1]
294738
0
Australia
Query!
Date submitted for ethics approval [1]
294738
0
04/04/2016
Query!
Approval date [1]
294738
0
07/07/2016
Query!
Ethics approval number [1]
294738
0
HREC/16/MHS/18
Query!
Summary
Brief summary
In Australia, hypoxic peripartum death (stillbirth or neonatal death of mature infants after the onset of labour in an otherwise healthy pregnancy) is one of the top three causes of mortality in singleton term pregnancies. In addition, there is significant neonatal morbidity (neonatal encephalopathy, respiratory distress, acidosis, admission to the neonatal intensive care unit) associated with intrapartum hypoxia. Furthermore, these babies frequently require rapid delivery by emergency caesarean section which carries considerably more maternal and neonatal risk than less urgent procedures. We have found that combining the fetal cerebro-umbilical ratio (CUR) (measured by ultrasound) as a functional measure of fetal wellbeing, and maternal serum placental growth factor (PlGF) as a biomarker of placental function, at >37 weeks of gestation defines women at greatest risk of fetal compromise in labour. We therefore propose a pilot randomised controlled trial (RCT) to test whether introduction of this test can reduce intrapartum fetal compromise at term. Our primary outcome measure of fetal compromise will be a composite of emergency caesarean section for fetal compromise or severe adverse neonatal outcomes (cord arterial pH <7.1 and/or Lactate >6 mmol/L or Base Excess >12 or Apgar <5 at 5 minutes) or fetal/neonatal death. A pre-labour test which identifies babies most at risk of compromise in labour will address a critically unmet need in obstetrics as there is currently no good antenatal test for the prediction or risk assessment for intrapartum fetal compromise at term.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
64746
0
Prof Sailesh Kumar
Query!
Address
64746
0
Mater Research Institute/University of Queensland
Aubigny Place, Raymond Terrace, South Brisbane, QLD 4101
Query!
Country
64746
0
Australia
Query!
Phone
64746
0
+617 3163 8844
Query!
Fax
64746
0
Query!
Email
64746
0
[email protected]
Query!
Contact person for public queries
Name
64747
0
Helen Sherrell
Query!
Address
64747
0
Mater Research Institute/University of Queensland
Aubigny Place, Raymond Terrace, South Brisbane, QLD 4101
Query!
Country
64747
0
Australia
Query!
Phone
64747
0
+617 3163 8592
Query!
Fax
64747
0
Query!
Email
64747
0
[email protected]
Query!
Contact person for scientific queries
Name
64748
0
Sailesh Kumar
Query!
Address
64748
0
Mater Research Institute/University of Queensland
Aubigny Place, Raymond Terrace, South Brisbane, QLD 4101
Query!
Country
64748
0
Australia
Query!
Phone
64748
0
+617 3163 8844
Query!
Fax
64748
0
Query!
Email
64748
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
This has not been approved by our Ethics
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
241
Study protocol
Publication: Sherrell H, Clifton V, Kumar S. Pre...
[
More Details
]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Predicting intrapartum fetal compromise at term using the cerebroplacental ratio and placental growth factor levels (PROMISE) study: Randomised controlled trial protocol.
2018
https://dx.doi.org/10.1136/bmjopen-2018-022567
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF