Condition category
Pregnancy and Childbirth
Date applied
08/12/2008
Date assigned
16/01/2009
Last edited
29/08/2014
Prospective/Retrospective
Prospectively 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

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 below 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 measures

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

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

http://www.uhns.nhs.uk/

Funders

Funder type

Charity

Funder name

The Smith and Nephew Foundation (UK)

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22833651

Publication citations

  1. 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.

Additional files

Editorial Notes