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 |
| Secondary identifying numbers | 1 |
- Submission date
- 15/01/2007
- Registration date
- 03/05/2007
- Last edited
- 10/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
Contact information
Prof Colm O Herlihy
Scientific
Scientific
UCD School of Medicine and Medical Science
University College Dublin
National Maternity Hospital
Holles Street
Dublin
2
Ireland
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | The effects on pudendal nerve motor latency |
| Secondary outcome measures | The difference in anaorectal manometry and continence scoring between the groups |
| Overall study start date | 01/02/2007 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Ireland
Study participating centre
UCD School of Medicine and Medical Science
Dublin
2
Ireland
2
Ireland
Sponsor information
Health Research Board of Ireland (Ireland)
Government
Government
73 Lower Baggot Street
Dublin
2
Ireland
| Website | http://www.hrb.ie/ |
|---|---|
"ROR" |
https://ror.org/003hb2249 |
Funders
Funder type
Government
Health Research Board of Ireland (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
