Condition category
Pregnancy and Childbirth
Date applied
15/01/2007
Date assigned
03/05/2007
Last edited
10/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Colm O Herlihy

ORCID ID

Contact details

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

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 measures

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

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

http://www.hrb.ie/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes