Contact information
Type
Scientific
Primary contact
Miss Lynn Dudley
ORCID ID
Contact details
University Hospital of North Staffordshire NHS Trust
Treatment Centre
Children's Services and Obstetrics
Academic Unit of Obstetrics and Gynaecology
Maternity Building
City General Site
Newcastle Road
Stoke-on-Trent
Staffordshire
ST4 6QG
United Kingdom
+44 (0)1782 552 058/434
lynn.dudley@uhns.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9098
Study information
Scientific title
Perineal REpair following Vaginal delivery complicated by an Infected Episiotomy Wound: a feasibility study for a randomised controlled trial
Acronym
PREVIEW
Study hypothesis
Many women will require suturing to facilitate healing of the trauma site. However, practice varies widely between care given and established professionally agreed standards. There is limited data on the prevalence and consequences of perineal wound infection. In addition, there is only a small amount of information relating to the impact that perineal wound infection has on women's well-being during the immediate and long-term post-natal period. Anecdotal evidence suggests the number of women reporting perineal infections and dehiscence in the community is increasing; however, systems to track these complications following hospital discharge are lacking. Given that postpartum management of perineal trauma is a core component of routine maternity care it is vital that a true estimate of the problem is established using standardised definitions of wound infection and at the same time determine best practice when treating dehisced perineal wounds.
Hypotheses:
1. What is the prevalence of perineal wound infection and dehiscence in the UK?
2. What factors at the time of primary repair are most likely to be associated with perineal wound infection and dehiscence prior to discharge to the community?
3. What factors following discharge home are most likely to be associated with perineal wound infection and dehiscence in the community?
4. What are women's experiences of perineal infection and dehiscence and what types of information and support are most likely to benefit their post-natal recovery?
5. What is the best management for perineal wound infection and wound dehiscence?
6. What is the feasibility of conducting a definitive randomised controlled trial (RCT) comparing re-suturing of dehisced perineal wounds versus healing by secondary intention and what are the implications in terms of health benefits and costs?
Ethics approval
North Wales Research Ethics Committee, 29/04/2010, ref: 10/WNO03/16
Study design
Computer-randomised controlled feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Dehisced perineal wounds
Intervention
The participants will be computer randomised into either immediate resuturing of their dehisced perineal wound in comparison to healing by secondary intention. Both groups will have an independent assessment of their perineal wound at 2 weeks and 6 weeks after trial entry. Both groups of participants will be asked to complete a questionnaire at 6 weeks, 3 months and 6 months after trial entry.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Time taken for the dehisced perineal wound to heal, assessed at 2 weeks, 6 weeks, 3 months and 6 months, respectively.
An independent assessment of the primary outcome will be conducted at 2 weeks and 6 weeks using a questionnaire format, the title of the questionnaire being:
'PREVIEW' Independent Perineal Assessment 2 weeks, and
'PREVIEW' Independent Assessment 6 weeks
Mothers will also complete questionnaires at 6 weeks, 3 months and 6 months, respectively, also assessing primary and secondary outcomes, the title of these questionnaires being:
'PREVIEW' Mothers questionnaire 6 weeks
'PREVIEW' Mothers questionnaire 3 months
'PREVIEW' Mothers questionnaire 6 months
Secondary outcome measures
1. Woman's satisfaction with aesthetic results of perineal wound at 6 months post-natal
2. Pain at 6 weeks, 3 and 6 months post-natal
3. Dyspareunia (painful intercourse) at 3 - 6 months
4. Rates of breastfeeding
Mothers will complete questionnaires at 6 weeks, 3 months and 6 months respectively, assessing primary and secondary outcomes, the title of these questionnaires being:
'PREVIEW' Mothers questionnaire 6 weeks
'PREVIEW' Mothers questionnaire 3 months
'PREVIEW' Mothers questionnaire 6 months
Overall trial start date
01/04/2009
Overall trial end date
01/04/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women (aged 18 - 40 years) referred to the perineal care clinic at the University Hospital of North Staffordshire
2. Dehisced perineal wound (spontaneous second, third or fourth tear or episiotomy)
3. Occurs within two weeks following childbirth
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Approximately 250 patients
Participant exclusion criteria
1. Women that have not given their written consent to participate in the study
2. Women who have delivered a stillborn infant
3. Women under the age of 16 years
4. Women who cannot speak English or cannot read or write
Recruitment start date
01/04/2009
Recruitment end date
01/04/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of North Staffordshire NHS Trust
Staffordshire
ST4 6QG
United Kingdom
Sponsor information
Organisation
University Hospital of North Staffordshire NHS Trust (UK)
Sponsor details
c/o Darren Clement
Research and Development Manager
Research and Development Department
North Staffordshire Medical Institute
Hartshill Road
Hartshill
Stoke-on-Trent
Staffordshire
ST4 7NY
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Smith and Nephew Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
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
Basic results (scientific)
Publication list
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22833651
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28188151
2017 nested qualitative study results in: http://www.ncbi.nlm.nih.gov/pubmed/28188152
Publication citations
-
Protocol
Dudley L, Kettle C, Carter P, Thomas P, Ismail KM, Perineal resuturing versus expectant management following vaginal delivery complicated by a dehisced wound (PREVIEW): protocol for a pilot and feasibility randomised controlled trial., BMJ Open, 2012, 2, 4, doi: 10.1136/bmjopen-2012-001458.