Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000786695
Ethics application status
Approved
Date submitted
7/07/2014
Date registered
24/07/2014
Date last updated
17/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial to determine the effect of a physiological (step) versus a standard action (slope) labour progress lines on the rate of spontaneous vaginal birth amongst low risk women in labour for the first time
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
Secondary ID [1] 284909 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal Labour 292375 0
Condition category
Condition code
Reproductive Health and Childbirth 292690 292690 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 'physiological' 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.
Intervention code [1] 289727 0
Diagnosis / Prognosis
Comparator / control treatment
The standard 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] 292535 0
Number of women recruited, proportion of potentially eligible women recruited and reasons women are not recruited
Timepoint [1] 292535 0
completion of the study
Primary outcome [2] 292536 0
Compliance with the trial interventions and reasons for non-compliance assessed using chart audit and a tool specifically designed for the study
Timepoint [2] 292536 0
completion of the study
Primary outcome [3] 292666 0
Completeness of data collection for secondary outcomes and proportion lost to follow-up
Timepoint [3] 292666 0
Completion of the study
Secondary outcome [1] 309165 0
Proportion of women receiving an artificial rupture of membranes
Timepoint [1] 309165 0
Birth
Secondary outcome [2] 309166 0
Proprtion of women requiring oxytocic augmentation
Timepoint [2] 309166 0
Birth
Secondary outcome [3] 309167 0
Proportion of women having an operative birth (forceps, vacuum extraction or Caesarean Section) and primary indication
Timepoint [3] 309167 0
Birth
Secondary outcome [4] 309168 0
Proportion of women having a primary postpartum haemorrhage (> 1500mL)
Timepoint [4] 309168 0
24 hours post birth
Secondary outcome [5] 309169 0
clinician compliance with partogram use assessed through chart audit
Timepoint [5] 309169 0
Birth
Secondary outcome [6] 309455 0
A composite of serious adverse outcomes for the infant defined as: Infant death (any fetal death after study entry or death of a live born infant within 7 days of age; or serious infant morbidity defined as, one or more of the following: active resuscitation, which includes intubation/cardiac massage and/or the need to ventilate; Hypoxic Ischemic Encephalopathy (HIE) 2 or 3 and /or seizures under 48 hours; Apgar score equals 4 at 5 minutes; cord pH less than 7.18 and /or base deficit greater than -10 (arterial cord blood taken in scenarios where cord blood sampling would normally be collected); admission to special care or neonatal intensive care unit (NICU) greater than 4 days; need for inspired oxygen greater than 30% and/or the need for Continuous Positive Airways Pressure (CPAP) or invasive ventilation; proven systemic infection in first 48 hours of life (treated with antibiotics) (excluding lethal congenital anomalies).
Timepoint [6] 309455 0
7 days post birth
Secondary outcome [7] 309456 0
Proportion of women having a Spontaneous Vaginal Birth (SVB)
Timepoint [7] 309456 0
Birth

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 iso-immunisation; 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
18 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 during the antenatal period. Upon assessment of active labour that attending midwife will obtain an opaque study envelope containing either an experimental or standard partogram labelled with a unique study code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Opaque envelopes containing partograms with pre printed stepped (intervention) or sloping (standard care) lines 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
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2015
Actual
16/01/2015
Date of last participant enrolment
Anticipated
15/05/2015
Actual
18/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
99
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2698 0
Mater Mother's Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 289536 0
Hospital
Name [1] 289536 0
Mater Health Services
Country [1] 289536 0
Australia
Primary sponsor type
Individual
Name
Prof Sue Kildea
Address
Mater Research Institute / University of Queensland
Raymond Terrace
South Brisbane
Queensland
Australia
4101
Country
Australia
Secondary sponsor category [1] 288222 0
None
Name [1] 288222 0
Address [1] 288222 0
Country [1] 288222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291276 0
Mater Health Services HREC
Ethics committee address [1] 291276 0
Ethics committee country [1] 291276 0
Australia
Date submitted for ethics approval [1] 291276 0
01/09/2014
Approval date [1] 291276 0
06/01/2015
Ethics approval number [1] 291276 0
EC00332

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49634 0
Dr Nigel Lee
Address 49634 0
Midwifery Research Unit
Mater Research Institute
Level 2 Aubigny Place
Raymond Terrace
South Brisbane
Queensland 4101
Country 49634 0
Australia
Phone 49634 0
61 7 31636118
Fax 49634 0
Email 49634 0
[email protected]
Contact person for public queries
Name 49635 0
Nigel Lee
Address 49635 0
Midwifery Research Unit
Mater Research Institute
Level 2 Aubigny Place
Raymond Terrace
South Brisbane
Queensland 4101
Country 49635 0
Australia
Phone 49635 0
61 7 31636118
Fax 49635 0
Email 49635 0
[email protected]
Contact person for scientific queries
Name 49636 0
Nigel Lee
Address 49636 0
Midwifery Research Unit
Mater Research Institute
Level 2 Aubigny Place
Raymond Terrace
South Brisbane
Queensland 4101
Country 49636 0
Australia
Phone 49636 0
61 7 31636118
Fax 49636 0
Email 49636 0
[email protected]

No information has been provided regarding IPD availability


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.