A study of position during the late stages of labour in women with an epidural

ISRCTN	ISRCTN35706297
DOI	https://doi.org/10.1186/ISRCTN35706297
Secondary identifying numbers	HTA 08/22/02; Version 1

Submission date: 19/08/2009
Registration date: 26/08/2009
Last edited: 18/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Epidurals are the most effective method of relieving pain during labour. About 150,000 women have epidurals during childbirth in the UK each year and they consistently report high levels of satisfaction. However, epidurals do have some disadvantages. Studies have shown that they increase the chance of women needing help to delivery their baby using forceps or vacuum suction. During an instrumental delivery a woman may need to have an episiotomy or my find it causes a tear in her birth canal as her baby is born. Instrumental deliveries also increase the risk of subsequently developing loss of bowel control (incontinence), leaking urine and suffering sexual problems after childbirth. There is debate about whether adopting an upright position during the late stage of labour, when the neck of the womb is fully open, gives a greater chance of having a normal vaginal birth. It is thought that an upright position may help by several different mechanisms: gravity may help align the baby more correctly in the birth canal and may increase the blood supply to the womb; it may also result in stronger contractions of the womb and assist a woman to push more effectively at delivery. At present few women who have an epidural are encouraged to be upright in the late stage of labour. Most adopt a position lying down or half-sitting in bed. However, advances in epidural pain relief over the last two decades have resulted in the widespread use of a technique that allows women to move around rather than to be immobile. This approach uses low doses of local anaesthetic, the drug which was responsible for leg weakness in old-style epidurals, together with another painkiller called fentanyl. With these 'mobile' epidurals, most women are able to move around safely whilst in labour, including the late stages of labour, and remain comfortable. Furthermore, the chance of needing an instrumental delivery is much less, although still greater than with no epidural. The aim of this study is to find out whether adopting an upright position throughout the second stage of labour decreases the need for instrumental vaginal delivery, compared with adopting a 'lying-down' position.

Who can participate?
Women who are in labour for the first time and who have an effective epidural, and for whom no complications are expected

What does the study involve?
Participating mothers are randomly allocated to one of two groups: one group is encouraged by the midwife to adopt as upright a posture as possible (this would include walking, standing, sitting out of bed or sitting bolt upright in bed) for as much as possible of the late stage of labour, right up to their baby's birth, and the other group are asked to adopt a lying down position in bed. The health of participating mothers and babies are measured up to 1 year after birth with a postal or telephone questionnaire.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
April 2010 to April 2015

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK)

Who is the main contact?
Prof Peter Brocklehurst
peter.brocklehurst@npeu.ox.ac.uk

Contact information

Prof Peter Brocklehurst
Scientific

National Perinatal Epidemiology Unit
University of Oxford
Old Road Campus
Headington
Oxford
OX3 7LF
United Kingdom

Phone	+44 (0)1865 289700
Email	peter.brocklehurst@npeu.ox.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A study of position during the late stages of labour in women with an epidural: a randomised controlled trial
Study acronym	BUMPES
Study hypothesis	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.
Ethics approval(s)	To be submitted before the end of September 2009
Condition	Labour/birthing position
Intervention	1. 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. 2. 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.
Intervention type	Behavioural
Primary outcome measure	Incidence of spontaneous vaginal delivery (SVD)
Secondary outcome measures	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
Overall study start date	01/04/2010
Overall study end date	30/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	3,000
Participant inclusion criteria	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
Participant exclusion criteria	Unable to understand written and spoken English language
Recruitment start date	01/04/2010
Recruitment end date	30/04/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Oxford

Oxford
OX3 7LF
United Kingdom

Sponsor information

University of Oxford (UK)
University/education

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headley Way
Oxford
OX3 9DZ
England
United Kingdom

Phone	+44 (0)1865 222757
Email	heather.house@admin.ox.ac.uk
Website	http://www.admin.ox.ac.uk/rso/clinical/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
Location: United Kingdom

Results and Publications

Intention to publish date	01/11/2016
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	18/10/2017		Yes	No

Editorial Notes

18/05/2018: Publication reference added.
15/04/2016: Plain English summary added.