Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000445572
Ethics application status
Approved
Date submitted
13/04/2015
Date registered
8/05/2015
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Date results information initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial to determine the effect of two designs of partographs, including labour progress lines, on the rate of spontaneous vaginal birth amongst low risk women in labour for the first time: The Partograph Trial
Scientific title
For women in labour for the first time does a partograph with a graduated dystocia line compared to a standard sloping action line increase the likelihood of a spontaneous vaginal birth: Pilot Partograph study 2
Secondary ID [1] 286517 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal Labour 294736 0
Condition category
Condition code
Reproductive Health and Childbirth 295023 295023 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Dystocia line partogram is a visual tool that uses a graduated (stepped) line to indicate whether cervical dilatation, determined by vaginal assessment at regular intervals, is slower than a mean of 0.5cm per hour. The tool is administered by a midwife and the results of vaginal assessments are recorded on the partograph every four hours or as clinically indicated.
Intervention code [1] 291610 0
Diagnosis / Prognosis
Comparator / control treatment
The standard Action line partogram is a visual tool that uses a sloping line to indicate whether cervical dilatation, determined by vaginal assessment at regular intervals, is slower than a mean of 1cm per hour.
Control group
Active

Outcomes
Primary outcome [1] 294781 0
Compliance with the trial interventions (appropriate commencement and use of assigned partogram) and reasons for non-compliance as assessed through audit of clinical record and allocated partograph
Timepoint [1] 294781 0
Birth
Secondary outcome [1] 314023 0
Proportion lost to follow-up determined through maintainence of a recruitment record
Timepoint [1] 314023 0
Six weeks postnatal
Secondary outcome [2] 314024 0
Proportion of women receiving an artificial rupture of membranes assesed using participant specific data provided from a perinatal database
Timepoint [2] 314024 0
Birth
Secondary outcome [3] 314025 0
Proprtion of women requiring oxytocic augmentation assesed using participant specific data provided from a perinatal database
Timepoint [3] 314025 0
Birth
Secondary outcome [4] 314026 0
Proportion of women having an operative birth (forceps, vacuum
extraction or Caesarean Section) and primary indication assesed using participant specific data provided from a perinatal database
Timepoint [4] 314026 0
Birth
Secondary outcome [5] 314027 0
Proportion of women having a primary postpartum haemorrhage (> 1500mL) assesed using participant specific data provided from a perinatal database
Timepoint [5] 314027 0
24 hours post birth
Secondary outcome [6] 314028 0
A composite of serious adverse outcomes for the infant defined as: Fetal death after study entry or neonatal death before discharge from hospital or in the first seven days excluding lethal abnormalities; Apgar score < 4 at five minutes; admission to SCN/NICU > 4 days (96 hours) assesed using participant specific data provided from a perinatal database.
Timepoint [6] 314028 0
96 hours post birth
Secondary outcome [7] 314029 0
Proportion of infants with: Apgar score <7 at 5 minutes assesed using participant specific data provided from a perinatal database
Timepoint [7] 314029 0
48 hours post birth
Secondary outcome [8] 314315 0
Proportion of infants with: any admission to Neonatal Intensive Care assesed using participant specific data provided from a perinatal database
Timepoint [8] 314315 0
Discharge from hospital
Secondary outcome [9] 314316 0
Proportion of infants with: Hypoxic Ischemic Encephalopathy 1, 2 and 3 assesed using participant specific data provided from a perinatal database
Timepoint [9] 314316 0
Discharge from hospital
Secondary outcome [10] 314317 0
Proportion of infants with: resuscitation, which includes mask ventilation for > 5 minutes, intubation for ventilation, cardiac massage and/or the administration of drugs of resuscitation (e.g. Adrenaline, Sodium Bicarbonate, Fluids) assesed using participant specific data provided from a perinatal database
Timepoint [10] 314317 0
Discharge from hospital
Secondary outcome [11] 314318 0
Proportion of infants with: Seizures under 48 hours assesed using participant specific data provided from a perinatal database
Timepoint [11] 314318 0
Dischrarge from hospital
Secondary outcome [12] 314319 0
Proportion of infants with: Cord pH <7.18 and/or base deficit <-10 (arterial cord blood) or lactate >6 assesed using participant specific data provided from a perinatal database
Timepoint [12] 314319 0
48 hours
Secondary outcome [13] 314320 0
Proportion of infants with: proven systemic infection (blood or deep tissue culture positive) in first 48 hours of life (treated with antibiotics) assesed using participant specific data provided from a perinatal database
Timepoint [13] 314320 0
Discharge from hospital
Secondary outcome [14] 314480 0
Completeness of data collection for secondary outcomes
Timepoint [14] 314480 0
Discharge of Mother and Infant from hospital

Eligibility
Key inclusion criteria
Nulliparous women in spontaneous labour who are:
* At term (between 37 and 41 weeks plus 6 days gestation) with a singleton pregnancy, a cephalic (head down) presentation and cervical
dilatation of 4cm or greater
* Equal to or greater than 18 years of age and able to provide informed
consent
* Defined as ‘low risk’ i.e. no history of: stillbirth or neonatal death, three or more consecutive miscarriages, previous fetal death in utero, previous
preterm birth (less than 32 weeks), previous mid-trimester loss/cervical incompetence/cone biopsy/known uterine anomaly, previous early onset of pre-eclampsia (less than 32 weeks gestation), or rhesus isoimmunisation;
no complications during the current pregnancy (such as
multiple pregnancy or fetal abnormality); and no precluding medical conditions (such as cardiac disease, essential hypertension, renal disease,
pre-existing diabetes, previous gestational diabetes, epilepsy, severe asthma, substance use, significant psychiatric disorders, age greater than
40 years, body mass indexless than 17 or greater than 35).
Minimum age
16 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Private insurance status (this refers to women who utilise their health insurance to access maternity care from an obstetrician of their choice)

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)
Participants will be consented to the trial when attending for assessment of early labour. Upon assessment of active labour (cervical dilatation of 4 cms or more) the attending midwife will obtain an opaque study envelope containing either an experimental Dystocia line partogram labelled with a unique study code or a form stating to use a standard partogram and record the study code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Opaque envelopes containing either a pre printed Dystocia line partograms a form of similar weight, stating to use a standard partogram, will be prepared by the Mater Research Institute using block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis
The sample size for this trial is based upon determining an accurate estimate of the compliance with the correct commencement and use of the relevant partograph in both the action line and dystocia line groups. With a sample size of 196 participants per group, the compliance proportion in each group can be reported along with a confidence level of 95% and a confidence interval width of 0.10, assuming a proportion of 85% (a proportion less than 85% will be deemed to be not high enough to continue with a full RCT without further amendments to the protocol). With the addition of 10% for attrition the overall sample size would be 218 per group (436 participants overall).
Simple descriptive stats will describe the primary outcomes of the pilot study. All women randomised will be analysed in their allocated treatment groups (ie. Intention to treat) by a researcher blinded to treatment allocation. Relative risks with 95% confidence intervals for the primary outcomes will be calculated. Secondary outcome measures of categorical data will be analysed with chi-squared tests and continuous data will be analysed with t-tests for normally distributed data and Mann–Whitney U test for parametric data. Linear regression (continuous outcomes) or logistic regression (binary outcomes) analysis will be undertaken if necessary to adjust for imbalances in potentially confounding variables (univariable then multivariable models). All study outcomes will be analysed using a two sided P value of < 0.05 to indicate statistical significance. The study is only powered for the primary outcomes and for secondary outcomes confidence intervals (CI) will be presented to estimate possible effect sizes. All withdrawals, losses to follow-up, and deaths will be reported.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2015
Actual
12/01/2016
Date of last participant enrolment
Anticipated
30/03/2016
Actual
10/11/2018
Date of last data collection
Anticipated
Actual
10/11/2018
Sample size
Target
436
Accrual to date
Final
246
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3690 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 9514 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 291082 0
Hospital
Name [1] 291082 0
Mater Health Services
Country [1] 291082 0
Australia
Primary sponsor type
Individual
Name
Prof Sue Kildea
Address
Molly Wardaguga Research Centre
College of Nursing & Midwifery
Charles Darwin University
Country
Australia
Secondary sponsor category [1] 289759 0
None
Name [1] 289759 0
Address [1] 289759 0
Country [1] 289759 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292665 0
Mater Health Services HREC
Ethics committee address [1] 292665 0
Mater Health Services
Raymond Terrace
South Brisbane
Queensland
4101
Ethics committee country [1] 292665 0
Australia
Date submitted for ethics approval [1] 292665 0
07/04/2015
Approval date [1] 292665 0
12/01/2016
Ethics approval number [1] 292665 0

Summary
Brief summary
The aim of this pilot study is to test the procedures for a larger trial that will compare two different tools (partographs) for measuring progress in labour. In particular we aim to achieve a compliance rate of 85% with both the intervention and control arms of the trial. The outcomes will inform any necessary changes to the main study protocol. If no substantial changes are required the data from this pilot study will be incorporated into the results of the main study
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56454 0
Dr Nigel Lee
Address 56454 0
School of Nursing Midwifery and Social Work
University of Queensland
Chamberlain Building
St Lucia
Country 56454 0
Australia
Phone 56454 0
61 7 31636118
Fax 56454 0
Email 56454 0
[email protected]
Contact person for public queries
Name 56455 0
Dr Nigel Lee
Address 56455 0
School of Nursing Midwifery and Social Work
University of Queensland
Chamberlain Building
St Lucia
Country 56455 0
Australia
Phone 56455 0
+61 0427231390
Fax 56455 0
Email 56455 0
[email protected]
Contact person for scientific queries
Name 56456 0
Dr Nigel Lee
Address 56456 0
School of Nursing Midwifery and Social Work
University of Queensland
Chamberlain Building
St Lucia
Country 56456 0
Australia
Phone 56456 0
+61 0427231390
Fax 56456 0
Email 56456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
summaries of de identified data
When will data be available (start and end dates)?
From October 2021 with no end date
Available to whom?
upon receipt of a suitable request and execution of a data sharing agreement
Available for what types of analyses?
summaries of de identified data
How or where can data be obtained?
Requests addressed to principal investigator ([email protected])


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.