Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001213538
Ethics application status
Approved
Date submitted
30/08/2015
Date registered
6/11/2015
Date last updated
24/01/2020
Date data sharing statement initially provided
24/01/2020
Type of registration
N/A

Titles & IDs
Public title
Ultrasound in the second stage of labour for fetal position – a randomised controlled trial
Scientific title
Evaluation of the clinical examination versus use of ultrasound with the clinical examination for assessing fetal head position on maternal and neonatal outcomes in women having a vacuum assisted birth.
Secondary ID [1] 287375 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
suction cup malposition 296061 0
Condition category
Condition code
Reproductive Health and Childbirth 296325 296325 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Digital vaginal examination will be as per current care.
The ultrasound will be performed by a senior obstetrician using a hand held transducer on the maternal abdomen to assess fetal head position. The procedure would take no more than a couple of minutes. Adherence will be noted on the study sheet completed for all women having a vacuum birth.
Intervention code [1] 292720 0
Prevention
Comparator / control treatment
Control group: current care that involves assessment by abdominal and digital vaginal examination prior to instrumental delivery. The clinician will notify the midwife of the fetal position prior to the vacuum and who will record the position on the chart provided as either direct OA or OP, left OA, right OA, left OP and right OP, left OT or right OT position. The rest of the information will be as is routinely collected on the instrumental delivery form currently used in the unit.
Control group
Active

Outcomes
Primary outcome [1] 295979 0
i) Position of the baby as assessed by the midwife ascribing the vacuum birth
Timepoint [1] 295979 0
This will be assessed at time of birth
Primary outcome [2] 296033 0
ii). Position of the cup placement noted at birth – this will be noted from the instrument markings on the neonatal head by the paediatric Registrar who is always present at these births
Timepoint [2] 296033 0
This will be assessed at time of birth
Secondary outcome [1] 317087 0
i). a composite outcome:
a. Neonatal trauma (bruising, laceration, cephalohaematoma, su bgaleal haemorrhage, retinal haemorrhage) as assessed by the paediatric Registrar
b. fetal acidosis (arterial pH below 7.10 and base excess greater than-12.0 mmol)
c. admission to the neonatal unit.
Timepoint [1] 317087 0
At time of birth
Secondary outcome [2] 317293 0
ii). Maternal: compare the incidence of>3 pulls- each pull is recorded by the scriber during the procedure with time of application of each pull as well
Timepoint [2] 317293 0
At time o fbirth
Secondary outcome [3] 317294 0
iii). number of pop offs - as recorded by scriber present during procedure
Timepoint [3] 317294 0
At time of birth-
Secondary outcome [4] 317295 0
iv). Third and fourth degree perineal tears- a mandatory requirement when perineum is examined after procedure on the assisted birth template
Timepoint [4] 317295 0
Immediately after birth
Secondary outcome [5] 317296 0
v). Maternal satisfaction of the instrumental delivery process.- assessed using a simple survey form with Likert scale
Timepoint [5] 317296 0
The day following the birth by a member of the Research team.
Secondary outcome [6] 318703 0
Sequential use of instruments - as recorded by the scriber present during the procedure
Timepoint [6] 318703 0
At time of birth
Secondary outcome [7] 318704 0
caesarean section for failed instrumental delivery - as recorded in teh birth Register
Timepoint [7] 318704 0
Immediately after birth

Eligibility
Key inclusion criteria
Gestational age 37 weeks or above, singleton, cephalic presentation and need for instrumental delivery.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Need for urgent delivery for fetal distress.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation: Allocation to intervention or the control group will be by opening a sequentially numbered sealed opaque envelope that will contain the allocation. Randomisation will be concealed in serially numbered sealed opaque envelopes kept locked in the ward and only opened immediately before a decision has been made to perform a vacuum birth and after recording the name and UR number of the participant in the research register. After randomisation the participant will remain in that group irrespective of the actual method used for of induction; intention-to-treat.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done by using a computer generated list of random numbers with a variable block size.
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
a. Sample size - If we assume the rate of inaccurate diagnosis (difference of more than 45 degrees) to be 20% in the control group based on previous studies, to demonstrate a rate of incorrect diagnosis of 5% in the intervention group, we would require 175 women in each group to have a power of 80% at an alpha value of 5%.

b. Data analysis and reporting will proceed according to CONSORT guidelines for randomised controlled trials, and will be conducted blinded to group status by the trial researcher. All analyses will use appropriate regression models, with results presented Relative risks with their respective 95% confidence intervals

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 4276 0
Ipswich Hospital - Ipswich

Funding & Sponsors
Funding source category [1] 291937 0
Self funded/Unfunded
Name [1] 291937 0
Country [1] 291937 0
Primary sponsor type
Individual
Name
kassam mahomed
Address
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld. 4305
Country
Australia
Secondary sponsor category [1] 290607 0
None
Name [1] 290607 0
Address [1] 290607 0
Country [1] 290607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293438 0
West Moreton District HREC
Ethics committee address [1] 293438 0
Human Research Ethics Committee EC00184
The Park – Centre for Mental Health
Locked Bag 500
Sumner Park BC, QLD 4074
Ethics committee country [1] 293438 0
Australia
Date submitted for ethics approval [1] 293438 0
20/07/2015
Approval date [1] 293438 0
21/08/2015
Ethics approval number [1] 293438 0
HREC/15/QMWS/16

Summary
Brief summary
A RCT to compare clinical examination alone versus clinical examination and ultrasound for accuracy of fetal head position prior to vacuum birth.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59930 0
A/Prof Kassam mahomed
Address 59930 0
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld 4305.
Country 59930 0
Australia
Phone 59930 0
+61738101111
Fax 59930 0
Email 59930 0
[email protected]
Contact person for public queries
Name 59931 0
A/Prof Kassam Mahomed
Address 59931 0
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld 4305.
Country 59931 0
Australia
Phone 59931 0
+61738101111
Fax 59931 0
Email 59931 0
[email protected]
Contact person for scientific queries
Name 59932 0
A/Prof Kassam mahomed
Address 59932 0
Dept of Obstetrics and Gynaecology
Ipswich Hospital
1 Chelmsford Avenue
Ipswich
Qld 4305.
Country 59932 0
Australia
Phone 59932 0
+61738101111
Fax 59932 0
Email 59932 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.