Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
POSINLAB
Study hypothesis
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
Ethics Committe of the National Maternity Hospital, 12/09/2002.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
The effects on pudendal nerve motor latency
Secondary outcome measures
The difference in anaorectal manometry and continence scoring between the groups
Overall trial start date
01/02/2007
Overall trial end date
30/06/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Primiparous healthy patients who are in labour with a single cephalic foetus
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant 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
Recruitment start date
01/02/2007
Recruitment end date
30/06/2007
Locations
Countries of recruitment
Ireland
Trial participating centre
UCD School of Medicine and Medical Science
Dublin
2
Ireland
Sponsor information
Organisation
Health Research Board of Ireland (Ireland)
Sponsor details
73 Lower Baggot Street
Dublin
2
Ireland
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Board of Ireland (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list