Trial Review

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
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
Scientific title
Predicting intrapartum fetal compromise at term using the fetal cerebro-umbilical ratio and placental growth factor (PROMISE Study)
Secondary ID [1] 288877 0
None
Universal Trial Number (UTN)
U1111-1181-3852
Trial acronym
PROMISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fetal compromise 298176 0
Condition category
Condition code
Reproductive Health and Childbirth 298337 298337 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 294369 0
Early detection / Screening
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.
Control group
Active

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.
Timepoint [1] 297857 0
Within 28 days of delivery of baby as this encompasses the entire neonatal period.
Secondary outcome [1] 322467 0
Incidence of birth weight <3rd centile or >97th centile - assessed by review of neonatal/birth record.
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.
Secondary outcome [2] 326125 0
Pathological UA dopplers (absent or reversed end diastolic flow) - assessed by review of antenatal USS records
Timepoint [2] 326125 0
Within 28 days of delivery of baby
Secondary outcome [3] 326126 0
Non-cephalic presentation - assessed by review of birth record and antenatal USS record
Timepoint [3] 326126 0
Within 28 days of delivery of baby
Secondary outcome [4] 326127 0
Intrapartum CTG abnormalities (suspicious/pathological fetal heart rate patterns) - assessed by review of Guardian record and birth record.
Timepoint [4] 326127 0
Within 28 days of delivery of baby
Secondary outcome [5] 326128 0
Meconium aspiration - assessed by review of neonatal record
Timepoint [5] 326128 0
Within 28 days of delivery of baby
Secondary outcome [6] 326129 0
Necrotizing enterocolitis - assessed by review of neonatal record
Timepoint [6] 326129 0
Within 28 days of delivery of baby
Secondary outcome [7] 326130 0
Neonatal hypoglycemia requiring intravenous glucose - assessed by review of neonatal record
Timepoint [7] 326130 0
Within 28 days of delivery of baby
Secondary outcome [8] 326131 0
Length of stay in SCN or NICU - assessed by review of neonatal record
Timepoint [8] 326131 0
Within 28 days of delivery of baby
Secondary outcome [9] 326132 0
Neonatal seizures - assessed by review of neonatal record
Timepoint [9] 326132 0
Within 28 days of delivery of baby
Secondary outcome [10] 326133 0
Neonatal encephalopathy - assessed by review of neonatal record
Timepoint [10] 326133 0
Within 28 days of delivery of baby
Secondary outcome [11] 326134 0
Neonatal death - assessed by review of neonatal record
Timepoint [11] 326134 0
Within 28 days of delivery of baby
Secondary outcome [12] 326135 0
Operative intervention (other than caesarean section) for intrapartum fetal compromise - assessed by review of labour/delivery record.
Timepoint [12] 326135 0
Within 28 days of delivery of baby
Secondary outcome [13] 326136 0
Intrapartum fetal blood sampling rates - assessed by review of labour/delivery record
Timepoint [13] 326136 0
Within 28 days of delivery of baby
Secondary outcome [14] 326137 0
Decision to birth time for operative deliveries - assessed by review of labour/delivery record
Timepoint [14] 326137 0
Within 28 days of delivery of baby
Secondary outcome [15] 326138 0
Maternal length of stay in hospital - assessed by review of medical record
Timepoint [15] 326138 0
Within 28 days of delivery of baby
Secondary outcome [16] 326139 0
Maternal admission to ICU - assessed by review of medical record
Timepoint [16] 326139 0
Within 28 days of delivery of baby
Secondary outcome [17] 326140 0
Maternal sepsis - assessed by review of medical record
Timepoint [17] 326140 0
Within 28 days of delivery of baby
Secondary outcome [18] 326141 0
Maternal deep vein thrombosis/pulmonary embolism - assessed by review of medical record
Timepoint [18] 326141 0
Within 28 days of delivery of baby
Secondary outcome [19] 326142 0
Other operative complications - assessed by review of medical record
Timepoint [19] 326142 0
Within 28 days of delivery of baby

Eligibility
Key inclusion criteria
Singleton pregnancy, with cephalic presentation, planning a vaginal birth.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
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.

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)
Sealed opaque envelopes
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2016
Actual
14/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
450
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5539 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 13005 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 293258 0
Charities/Societies/Foundations
Name [1] 293258 0
Mater Foundation
Country [1] 293258 0
Australia
Primary sponsor type
Hospital
Name
Mater Health Services
Address
Raymond Terrace, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 292062 0
None
Name [1] 292062 0
Address [1] 292062 0
Country [1] 292062 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294738 0
Mater Human Research Ethics Committee
Ethics committee address [1] 294738 0
Mater Medical Research Institute
Raymond Terrace, South Brisbane, QLD 4101
Ethics committee country [1] 294738 0
Australia
Date submitted for ethics approval [1] 294738 0
04/04/2016
Approval date [1] 294738 0
07/07/2016
Ethics approval number [1] 294738 0
HREC/16/MHS/18

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64746 0
Prof Sailesh Kumar
Address 64746 0
Mater Research Institute/University of Queensland
Aubigny Place, Raymond Terrace, South Brisbane, QLD 4101
Country 64746 0
Australia
Phone 64746 0
+617 3163 8844
Fax 64746 0
Email 64746 0
[email protected]
Contact person for public queries
Name 64747 0
Dr Helen Sherrell
Address 64747 0
Mater Research Institute/University of Queensland
Aubigny Place, Raymond Terrace, South Brisbane, QLD 4101
Country 64747 0
Australia
Phone 64747 0
+617 3163 8592
Fax 64747 0
Email 64747 0
[email protected]
Contact person for scientific queries
Name 64748 0
Prof Sailesh Kumar
Address 64748 0
Mater Research Institute/University of Queensland
Aubigny Place, Raymond Terrace, South Brisbane, QLD 4101
Country 64748 0
Australia
Phone 64748 0
+617 3163 8844
Fax 64748 0
Email 64748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been approved by our Ethics


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
241Study 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
SourceTitleYear of PublicationDOI
EmbasePredicting intrapartum fetal compromise at term using the cerebroplacental ratio and placental growth factor levels (PROMISE) study: Randomised controlled trial protocol.2018https://dx.doi.org/10.1136/bmjopen-2018-022567
N.B. These documents automatically identified may not have been verified by the study sponsor.