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
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
-
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.