Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001308583
Ethics application status
Approved
Date submitted
25/08/2015
Date registered
30/11/2015
Date last updated
30/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of pregnant women being monitored during labour with ST analysis monitoring and cardiotocography, compared to being monitored with cardiotocography alone, in order to reduce caesarean section whilst still having comparable outcomes for the baby.
Scientific title
In pregnant women with a singleton pregnancy at greater than 36 weeks gestation, having intrapartum monitoring, how does ST analysis (STan) intrapartum monitoring compare to conventional cardiotocography for selected neonatal and maternal outcomes
Secondary ID [1] 287347 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intrapartum fetal monitoring 296008 0
Condition category
Condition code
Reproductive Health and Childbirth 296288 296288 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1; Cardiotocographic monitoring only, using a external fetal doppler heart rate transducer strapped around the maternal waist or a metal scalp clip attached to the babies scalp, along with an external tocodynometer strapped to the mothers pregnant abdomen. These transducers and pressure monitors are attached to an electronic fetal monitor (CTG machine), which produces a graphic correlation of fetal heart rate to uterine activity. Trained medical and midwifery staff interpret these temporal correlations according to established guidelines.
Arm 2: ST analysis (STan) fetal monitoring and cardiotocographic monitoring, using a specialised machine (Neovena STan monitor) that combines cardiotocographic monitoring (as above) with an electrocardiographic (ECG) recording of fetal cardiac activity, requiring a metal scalp clip attached to the unborn babies scalp. This monitoring is only commenced once the cervix is dilated enough and the membranes are ruptured, allowing the clip to be attached. A computerised analysis of the fetal ECG ST segment by the STan monitor provides additional information that is interpreted by guidelines developed by Neoventa by trained medical and midwifery staff.
The randomisation is performed when the decision is made during labour by medical or midwifery staff that electronic fetal monitoring is necessary, and the monitoring is continued until delivery of the baby.
Intervention code [1] 292684 0
Treatment: Devices
Comparator / control treatment
The control group has electronic fetal monitoring by cardiotocography (CTG) only. The intervention group has electronic fetal monitoring by ST analysis (STan ) fetal monitoring as well as CTG monitoring. The CTG monitoring is started during labour, and the STan monitoring is commenced in the intervention group only after application of a fetal scalp clip becomes possible (sufficient cervical dilatation and ruptured membranes). Monitoring in both groups is continued until the baby is born.
Control group
Active

Outcomes
Primary outcome [1] 295939 0
Caesarean section rate
Timepoint [1] 295939 0
Delivery mode observed of the index pregnancy
Secondary outcome [1] 316979 0
Instrumental vaginal delivery (rate), assessed by review of hospital records
Timepoint [1] 316979 0
At time of delivery of the baby.
Secondary outcome [2] 316980 0
Health costs
Data will be collected from various clinical feeder systems, conforming to National Hospital Cost Data Collection standards. Direct cost comparisons will be made using Australian Related Diagnosis Groups classification. Out of pocket costs will also be collected in the 7-week postnatal questionnaire, using the Labour Experience Questionnaire.
Timepoint [2] 316980 0
Duration of pregnancy and 7 weeks post partum
Secondary outcome [3] 316981 0
Psychosocial outcomes, including satisfaction
This will be measured by a questionnaire posted to women 7-weeks after delivery, using the Early Labour Experience Questionnaire, the Tilburg Pregnancy Distress Scale and the Edinburgh Postnatal Depression Scale. Additionally we will conduct a qualitative study to attain an in-depth understanding of women’s experiences with labour care and fetal monitoring.
Timepoint [3] 316981 0
Outcomes observed up to 7 weeks postnatally
Secondary outcome [4] 319244 0
Adverse neonatal outcome (composite of intrapartum fetal death, neonatal death, Apgar score of 3 at 5 minutes, seizure(s), cord artery pH 7.05 and base deficit 12 mmol/L, intubation for ventilation at delivery, or presence of neonatal encephalopathy)
Timepoint [4] 319244 0
Neonatal outcomes observed as a result of the index pregnancy before neonatal discharge from the hospital

Eligibility
Key inclusion criteria
At least 18 years and capable of giving consent. Pregnancy expected to labour and deliver vaginally, singleton fetus, cephalic presentation, suitable for STan monitoring.
Gestation must be greater than 36 completed weeks.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Planned caesarean section; placenta praevia; low placenta; active vaginal infection; active genital herpes; HIV positive.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women are informed of the study by a written handout and discussion with a clinician at 32 to 36 weeks gestation, with an opportunity to discuss the trial with family or friends. Consent is sought after the information has been given, or upon admission to the labour ward. After admission to labour ward, and the decision is made for CTG monitoring, eligibility criteria is reviewed, and if eligible, telephone based randomisation is performed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A telephone based randomisation system (NH&MRC clinical trials centre) will: request appropriate patient details and stratification factors; perform duplicate patient test for the current pregnancy based on collected patient details; perform randomisation using minimisation (incorporating stratifications); and send a confirmation of randomisation fax/email to the site.
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
Primary outcome for hypothesis (Caesarean section) and categorical variables will be analysed with risk-difference and 95% CI and continuous variables with a t-test. Intergroup comparisons will be performed using intention to treat and per protocol analysis.

Powering the primary hypothesis on a reduction of emergency caesarean section from 18% to 12%, with a power of 80% and a significance level (alpha) of 0.05, will require a total sample size of 1,176 women (588 women in the STan arm, 588 women in the CTG only arm). (http://statpages.org/proppowr.html).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1176
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4265 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 10208 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 291909 0
Hospital
Name [1] 291909 0
Women's and Children's Hospital
Country [1] 291909 0
Australia
Primary sponsor type
Individual
Name
Chris Wilkinson
Address
Women's and Children's Hospital
72 King William Rd
North Adelaide 5006
South Australia
Country
Australia
Secondary sponsor category [1] 290577 0
Individual
Name [1] 290577 0
Dr Sabrina Kuah
Address [1] 290577 0
Women's and Children's Hospital
72 King William Rd
North Adelaide 5006
South Australia
Country [1] 290577 0
Australia
Secondary sponsor category [2] 290578 0
Individual
Name [2] 290578 0
Dr Geoff Matthews
Address [2] 290578 0
Women's and Children's Hospital
72 King William Rd
North Adelaide 5006
South Australia
Country [2] 290578 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293416 0
WCHN human research ethics comittee
Ethics committee address [1] 293416 0
Level 2, Samuel Way Building
72 King William Rd
North Adelaide
South Australia
5006
Ethics committee country [1] 293416 0
Australia
Date submitted for ethics approval [1] 293416 0
Approval date [1] 293416 0
24/06/2015
Ethics approval number [1] 293416 0
HREC/14/WCHN/145

Summary
Brief summary
This is a randomised controlled trial comparing a programme of monitoring unborn babies during labour using ST analysis (STan) of fetal ECG to intrapartum cardiotography. We aim to reduce our emergency caesarean section rate from 18% to 12% with improvement or clinical equivalence of neonatal outcomes, whilst maintaining maternal wellbeing and both maternal and caregiver satisfaction. The WCH is the first Australian centre to introduce STan fetal monitoring, as a part of a comprehensive educational package on fetal monitoring.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59834 0
Dr Chris Wilkinson
Address 59834 0
WCH Maternal Fetal Medicine
72 King William Rd
North Adelaide
South Australia
5006
Country 59834 0
Australia
Phone 59834 0
61 8 81617633
Fax 59834 0
Email 59834 0
chrisswilkinson@mac.com
Contact person for public queries
Name 59835 0
Dr Sabrina Kuah
Address 59835 0
WCH Delivery Suite
72 King William Rd
North Adelaide
South Australia
5006
Country 59835 0
Australia
Phone 59835 0
61 8 81617633
Fax 59835 0
Email 59835 0
sabrina.kuah@health.sa.gov.au
Contact person for scientific queries
Name 59836 0
Dr Chris Wilkinson
Address 59836 0
WCH Maternal Fetal Medicine
72 King William Rd
North Adelaide
South Australia
5006
Country 59836 0
Australia
Phone 59836 0
61 8 81617633
Fax 59836 0
Email 59836 0
chrisswilkinson@mac.com

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
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