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ISRCTN
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ISRCTN35706297
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ClinicalTrials.gov identifier
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Public title
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A study of position during the late stages of labour in women with an epidural - the BUMPES study
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Scientific title
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A study of position during the late stages of labour in women with an epidural - BUMPES: a randomised controlled trial
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Acronym
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BUMPES
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Serial number at source
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HTA 08/22/02; Version 1
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Study hypothesis
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In nulliparous women who chose mobile epidural anaesthesia, does a policy of adopting an 'upright position' throughout the second stage of labour cause an increase in the incidence of spontaneous vaginal delivery (SVD) compared with a policy of adopting a 'lying-down' position.
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Lay summary
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Ethics approval
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To be submitted before the end of September 2009 (as of 19/08/2009)
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Labour/ birthing position
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Participants - inclusion criteria
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Women who are:
1. Nulliparous
2. Single cephalic presentation
3. Greater than or equal to 37 weeks gestation
4. Intend spontaneous vaginal birth
5. In second stage of labour
6. With an effective mobile epidural in situ
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Participants - exclusion criteria
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Unable to understand written and spoken English language
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Anticipated start date
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01/04/2010
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Anticipated end date
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30/04/2015
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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3,000
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Interventions
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'Upright position' vs 'lying-down' position throughout the second stage of labour.
Women allocated to an 'upright position' would aim to be in positions where their pelvis is in as vertical a plane as possible during the second stage of labour.
Women allocated to a 'lying-down position' would aim to be in positions where their pelvis is in as horizontal a plane as possible during the second stage of labour.
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Primary outcome measure(s)
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Incidence of spontaneous vaginal delivery (SVD)
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Secondary outcome measure(s)
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1. Mode of delivery
2. Outcomes from randomisation until delivery
3. Immediate post delivery outcomes
4. Postnatal period for both mother and infant
5. 1 year outcomes for both mother and infant
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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Contact name
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Prof
Peter
Brocklehurst
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Address
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National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LF
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Country
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United Kingdom
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Tel
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+44 (0)1865 289700
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Fax
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+44 (0)1865 289701
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Email
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peter.brocklehurst@npeu.ox.ac.uk
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Sponsor
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University of Oxford (UK)
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Address
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Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headley Way
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City/town
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Oxford
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Zip/Postcode
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OX3 9DZ
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Country
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United Kingdom
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Tel
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+44 (0)1865 222757
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Fax
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+44 (0)1865 743002
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Email
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heather.house@admin.ox.ac.uk
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Sponsor website:
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http://www.admin.ox.ac.uk/rso/clinical/
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Date applied
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19/08/2009
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Last edited
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26/08/2009
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Date ISRCTN assigned
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26/08/2009
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