Open Access Highly Accessed Study protocol

PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial

Debra E Bick1*, Christine Kettle23, Sue Macdonald4, Peter W Thomas5, Robert K Hills6 and Khaled MK Ismail37

Author Affiliations

1 King's College London, Florence Nightingale School of Nursing and Midwifery, James Clerk Maxwell Building, 57 Waterloo Road, London, UK

2 Faculty of Health, Staffordshire University, Blackheath Lane, Stafford, UK

3 University Hospital of North Staffordshire, Maternity Centre, Stoke on Trent, Staffordshire, UK

4 Royal College of Midwives, 15 Mansfield Street, London, UK

5 Dorset Research and Development Support Unit, School of Health and Social Care, Bournemouth University, Royal London House, Christchurch Road, Bournemouth, Dorset, UK

6 Department of Haematology, Cardiff University School of Medicine, Heath Park, Cardiff, UK

7 Institute of Science and Technology, in Medicine, Keele University Medical School, Keele, Staffordshire, UK

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BMC Pregnancy and Childbirth 2010, 10:10  doi:10.1186/1471-2393-10-10

Published: 25 February 2010

Abstract

Background

The Perineal Assessment and Repair Longitudinal Study (PEARLS) is a national clinical quality improvement initiative designed to improve the assessment and management of perineal trauma. Perineal trauma affects around 85% of women who have a vaginal birth in the UK each year and millions more world-wide. Continuous suturing techniques compared with traditional interrupted methods are more effective in reducing pain and postnatal morbidity, however they are not widely used by clinicians despite recommendations of evidence based national clinical guidelines. Perineal suturing skills and postnatal management of trauma remain highly variable within and between maternity units in the UK as well as worldwide. Implementation of a standardised training package to support effective perineal management practices could reduce perineal pain and other related postnatal morbidity for a substantial number of women.

Methods/Design

PEARLS is a matched pair cluster trial, which is being conducted in maternity units across the UK. Units within a matched pair will be randomised to implement the study intervention either early or late in the study period. The intervention will include the cascading of a multi-professional training package to enhance midwifery and obstetric skills in the assessment, repair and postnatal management of perineal trauma. Women who have had an episiotomy or second degree perineal tear will be eligible for recruitment. Prior to developing the intervention and deciding on study outcomes, a Delphi survey and a consensus conference were held to identify what women, who previously suffered perineal trauma during childbirth, considered to be important outcomes for them. Findings from this preliminary work (which will be reported elsewhere) and other outcomes including women's experiences of perineal pain and pain on activity, breastfeeding uptake and duration and psychological well-being as assessed using the Edinburgh Postnatal Depression Scale (EPDS) will be assessed at 10 days and three months post-birth.

Discussion

Implementation of evidence-based perineal assessment and management practices, could lead to significantly improved physical and psychological health outcomes for women in the UK and world-wide.

Trial registration

PEARLS is registered with the Current Controlled Trials Registry (no: ISRCTN28960026). NIHR UKCRN portfolio no: 4785.