A randomised controlled trial investigating the effect of POSition IN LABour and effect on pudendal nerve physiology

ISRCTN	ISRCTN86358094
DOI	https://doi.org/10.1186/ISRCTN86358094
Protocol serial number	1
Sponsor	Health Research Board of Ireland (Ireland)
Funder	Health Research Board of Ireland (Ireland)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof Colm O Herlihy
Scientific

UCD School of Medicine and Medical Science
University College Dublin
National Maternity Hospital
Holles Street
Dublin
2
Ireland

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	POSINLAB
Study objectives	The hypothesis of the trial is that direct pressure on the pudendal nerve and or sacral plexus during the first stage of labour rather than traction on the pelvic floor during the second stage of labour is supported by previous observations of our research group. Firstly pudendal nerve latency has been consistently shown to be prolonged more on the left than on the right. Secondly caesarean delivery late in labour does not prevent changes in pudendal nerve terminal motor latency.
Ethics approval(s)	Ethics Committe of the National Maternity Hospital, 12/09/2002.
Health condition(s) or problem(s) studied	Pudendal nerve neuropathy
Intervention	It is proposed to randomise sixty primparous women in the first stage of labour to conventional nursing on the left side or nursing on alternate sides every 30 minutes. Delivery would be in the left lateral position in group one and in the lithotomy positon in group two. Pelvic floor Electromyography (EMG), anorectal manometry and continence scoring would be performed at the six week postnatal check.
Intervention type	Other
Primary outcome measure(s)	The effects on pudendal nerve motor latency
Key secondary outcome measure(s)	The difference in anaorectal manometry and continence scoring between the groups
Completion date	30/06/2007

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	60
Key inclusion criteria	Primiparous healthy patients who are in labour with a single cephalic foetus
Key exclusion criteria	1. Patients with a history of bowel symptoms or bowel surgery 2. Patients without fluent English 3. Diabetic patients 4. Patients attending the hospital High Risk Clinic
Date of first enrolment	01/02/2007
Date of final enrolment	30/06/2007

UCD School of Medicine and Medical Science

Dublin
2
Ireland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan