Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000307505
Ethics application status
Approved
Date submitted
6/03/2001
Date registered
6/03/2001
Date last updated
6/03/2001
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fetal intrapartum pulse oximetry to reduce operative delivery rates in the presence of a non-reassuring fetal heart rate: a multicentre randomised controlled trial (the FOREMOST trial).
Scientific title
Fetal intrapartum pulse oximetry to reduce operative delivery rates in the presence of a non-reassuring fetal heart rate: a multicentre randomised controlled trial (the FOREMOST trial).
Secondary ID [1] 26 0
Perinatal Trials Registry: PTR360
Universal Trial Number (UTN)
Trial acronym
The FOREMOST trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-reassuring fetal status during labour 26 0
Condition category
Condition code
Reproductive Health and Childbirth 30 30 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Duration of Study: July 1999 to September 2004.
Experimental group receive conventional CTG monitoring plus fetal oxygen saturation monitoring using an internal fetal sensor.
Nellcor N-400/FS14 Monitor
Purpose: to determine whether the addition of fetal oximetry (oxygen values) to normal monitoring could help reduce the number of times caesarean sections, vacuum and forceps births were performed for concern about the well-being of the baby during labour.
Intervention code [1] 1156 0
Diagnosis / Prognosis
Comparator / control treatment
Control group receive conventional cardiotocograph (CTG) monitoring in labour.
Control group
Active

Outcomes
Primary outcome [1] 57 0
Operative delivery for non reassuring fetal status (NRFS)
Timepoint [1] 57 0
Measured at the time of the birth of the baby
Secondary outcome [1] 83 0
Staff perceptions of sensor placement.
Timepoint [1] 83 0
Outcome measured soon after placing the oximetry sensor.
Secondary outcome [2] 84 0
Operative delivery for other indications; fetal/neonatal variables (Apgar scores, umbilical and venous pH).
Timepoint [2] 84 0
Outcomes measured at or close to the time of birth.
Secondary outcome [3] 85 0
Admission to Neonatal Intensive Care Unit, (hypoxic-ixchaemic encephalopathy, death).
Timepoint [3] 85 0
Outcomes measured within a few days of birth.
Secondary outcome [4] 86 0
Maternal perceptions of their experience in the research project.
Timepoint [4] 86 0
Outcome measured within a few days of giving birth and again three months later.

Eligibility
Key inclusion criteria
Women in labour at > or = 36 weeks gestation with a non-reasuring CTG pattern.
Minimum age
16 Years
Maximum age
44 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple gestation; non-vertex presentation; placenta praevia; abrnp? placenta; APH; fetal anomaly; known significant viral infection (eg HIV); contraindication to invasive fetal monitoring

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)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation, block size 10-20. Stratification by previous caesarean section and hospital.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 38 0
Government body
Name [1] 38 0
National Health & Medical Research Council
Country [1] 38 0
Australia
Funding source category [2] 39 0
Charities/Societies/Foundations
Name [2] 39 0
Utah Foundation (UQ)
Country [2] 39 0
Australia
Funding source category [3] 40 0
University
Name [3] 40 0
Mayne Bequest (UQ)
Country [3] 40 0
Australia
Funding source category [4] 41 0
Commercial sector/Industry
Name [4] 41 0
Tyco Inc (Nellcor)
Country [4] 41 0
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital, The University of Queensland,Perinatal Research Centre
Address
Country
Australia
Secondary sponsor category [1] 35 0
None
Name [1] 35 0
Nil
Address [1] 35 0
Country [1] 35 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309 0
Royal Brisbane & Women's Hospital
Ethics committee address [1] 309 0
Ethics committee country [1] 309 0
Australia
Date submitted for ethics approval [1] 309 0
Approval date [1] 309 0
08/06/1997
Ethics approval number [1] 309 0
RWH 97/09
Ethics committee name [2] 310 0
Mater Mothers' Hospital
Ethics committee address [2] 310 0
Ethics committee country [2] 310 0
Australia
Date submitted for ethics approval [2] 310 0
Approval date [2] 310 0
Ethics approval number [2] 310 0
382M
Ethics committee name [3] 311 0
Royal Women's Hospital
Ethics committee address [3] 311 0
Ethics committee country [3] 311 0
Australia
Date submitted for ethics approval [3] 311 0
Approval date [3] 311 0
Ethics approval number [3] 311 0
99/38
Ethics committee name [4] 312 0
Royal Hospital for Women
Ethics committee address [4] 312 0
Ethics committee country [4] 312 0
Australia
Date submitted for ethics approval [4] 312 0
Approval date [4] 312 0
15/02/2002
Ethics approval number [4] 312 0
01/243
Ethics committee name [5] 313 0
University of Queensland
Ethics committee address [5] 313 0
Ethics committee country [5] 313 0
Australia
Date submitted for ethics approval [5] 313 0
Approval date [5] 313 0
Ethics approval number [5] 313 0
H317

Summary
Brief summary
Current methods of monitoring the well-being of the unborn baby during labour often result in concern about the unborn baby's health. This leads to delivery by caesarean section, forceps, or vacuum. These babies are usually found to be healthy once born, meaning that the operation was unnecessary. In this study, when an unborn baby appears to be distressed, half of the study participants will be allocated to continue with the current monitoring of the baby's heartbeat. The other half will have a new form of monitoring, fetal oxygen saturation monitoring, added. We will then determine whether the new form of monitoring makes a difference int he number of times women need to have a caesarian section, forceps or vacuum delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35955 0
Address 35955 0
Country 35955 0
Phone 35955 0
Fax 35955 0
Email 35955 0
Contact person for public queries
Name 10345 0
Christine East
Address 10345 0
Perinatal Research Centre
The University of Queensland
Royal Brisbane and Women’s Hospital
Butterfield St
Herston QLD 4029
Country 10345 0
Australia
Phone 10345 0
+61 7 36362349
Fax 10345 0
+61 7 36362123
Email 10345 0
[email protected]
Contact person for scientific queries
Name 1273 0
Christine East
Address 1273 0
Perinatal Research Centre
The University of Queensland
Royal Brisbane and Women’s Hospital
Butterfield St
Herston QLD 4029
Country 1273 0
Australia
Phone 1273 0
+61 7 36362349
Fax 1273 0
Email 1273 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.