Randomised controlled trial of restrictive versus routine use of episiotomy for instrumental delivery - a multicentre pilot study

ISRCTN ISRCTN69736659
DOI https://doi.org/10.1186/ISRCTN69736659
Secondary identifying numbers T03/23
Submission date
19/01/2006
Registration date
20/04/2006
Last edited
07/12/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Deirdre Murphy
Scientific

Division of Maternal and Child Health Sciences
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Phone +44 (0)1382 496703
Email d.j.murphy@dundee.ac.uk

Study information

Study designRandomised controlled, multicentre pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesAim to assess the effects of restrictive use of episiotomy compared with routine use during instrumental vaginal delivery
Ethics approval(s)Ethical approval granted on 12/08/2004, reference number 04/MRE10/29
Health condition(s) or problem(s) studiedInstrumental vaginal delivery
InterventionRestrictive versus routine use of episiotomy
Intervention typeOther
Primary outcome measureThird or fourth degree perineal tears
Secondary outcome measures1. Mother's perception of pain
2. Length of postnatal hospital stay
3. Rate of maternal healing complications
4. Neonatal trauma
Overall study start date01/09/2004
Completion date31/08/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants200
Key inclusion criteria1. Primgravidae
2. Singleton
3. Cephalic presentation
4. At term ( >37 weeks gestation)
5. No contraindications to vaginal delivery
Key exclusion criteria1. Poor English
2. Maternal age <16 years
3. Inability to provide informed consent
Date of first enrolment01/09/2004
Date of final enrolment31/08/2006

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

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

Sponsor information

University of Dundee (UK)
University/education

Research and Innovation Services
Dundee
DD1 4HN
Scotland
United Kingdom

ROR logo "ROR" https://ror.org/03h2bxq36

Funders

Funder type

Charity

Tenovus Scotland T03/23

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2008 Yes No