Condition category
Pregnancy and Childbirth
Date applied
19/01/2006
Date assigned
20/04/2006
Last edited
07/12/2010
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 Deirdre Murphy

ORCID ID

Contact details

Division of Maternal and Child Health Sciences
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 496703
d.j.murphy@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

T03/23

Study information

Scientific title

Acronym

Study hypothesis

Aim to assess the effects of restrictive use of episiotomy compared with routine use during instrumental vaginal delivery

Ethics approval

Ethical approval granted on 12/08/2004, reference number 04/MRE10/29

Study design

Randomised controlled, multicentre pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Instrumental vaginal delivery

Intervention

Restrictive versus routine use of episiotomy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Third or fourth degree perineal tears

Secondary outcome measures

1. Mother's perception of pain
2. Length of postnatal hospital stay
3. Rate of maternal healing complications
4. Neonatal trauma

Overall trial start date

01/09/2004

Overall trial end date

31/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primgravidae
2. Singleton
3. Cephalic presentation
4. At term ( >37 weeks gestation)
5. No contraindications to vaginal delivery

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Poor English
2. Maternal age <16 years
3. Inability to provide informed consent

Recruitment start date

01/09/2004

Recruitment end date

31/08/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Maternal and Child Health Sciences
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research and Innovation Services
Dundee
DD1 4HN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Tenovus Scotland T03/23

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

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19035944

Publication citations

  1. Results

    Murphy DJ, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B, A randomised controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre pilot study., BJOG, 2008, 115, 13, 1695-702; discussion 1702-3, doi: 10.1111/j.1471-0528.2008.01960.x.

Additional files

Editorial Notes