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The PErineal Assessment and Repair Longitudinal Study (PEARLS): a national quality improvement initiative to improve the assessment and immediate, short and long term management of perineal trauma
ISRCTN ISRCTN28960026
DOI 10.1186/ISRCTN28960026
ClinicalTrials.gov identifier
EudraCT number
Public title The PErineal Assessment and Repair Longitudinal Study (PEARLS): a national quality improvement initiative to improve the assessment and immediate, short and long term management of perineal trauma
Scientific title
Acronym PEARLS
Serial number at source 07/MRE12/2
Study hypothesis That the provision of an evidence based training package and its delivery to practitioners will lead to better outcomes for women following perineal trauma.
Lay summary Not provided at time of registration
Ethics approval Thames Valley Research Ethics Committee, University of Reading. Approved in February 2007.
Study design Randomised controlled trial using a matched pair cluster design. Maternity units are the unit of randomisation.
Countries of recruitment United Kingdom
Disease/condition/study domain Perineal trauma
Participants - inclusion criteria All women who sustain a second degree perineal tear or episiotomy in a participating unit during the study period will be eligible. To avoid problems with selection biases, overall outcomes for the centre will be ascertained using audit data from birth records. All births during a prespecified period will contribute to these analyses.
Participants - exclusion criteria 1. Women under 16 years of age
2. Non-English speakers
3. Those who have suffered pregnancy loss
Anticipated start date 01/12/2005
Anticipated end date 01/02/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.
Target number of participants 1,000
Interventions A paired cluster design trial investigating the intervention of an evidence based, standardised training package delivered to midwives and obstetricians, in the assessment and management of perineal trauma. Twenty-four maternity units have been recruited and matched into 12 pairs. The training intervention will initially commence in one unit in each 'pair' (Group A) with it's matched partner continuing to provide usual care (Group B).

All women in participating units will receive written information antenatally, at around 36 weeks. Following birth, further information about the study will be provided, and informed consent obtained on the Labour Ward, or prior to discharge. Women who participate will receive a pack to take home including a covering letter, 10-12 day questionnaire and a Self Addressed Envelope (SAE). Following receipt of the first questionnaire, the second questionnaire will be sent with an SAE at 3 months.

Main study outcomes will be assessed at three months following cascading of the intervention in Group A units. The intervention will then be cascaded among Group B units.

Please use the following contact details to request a patient information sheet:
Sue Tohill/ Linda Lucking
PEARLS Central Office
Academic Unit of Obstetrics & Gynaecology
University Hospital of North Staffordshire
Newcastle Road
Stoke on Trent, ST4 6QG, UK
Linda Lucking:
Tel: +44 (0)1782 552484; Fax: +44 (0)1782 552472; Email: Linda.Lucking@uhns.nhs.uk
Sue Tohill:
Tel: +44 (0)7880 942330; Email: sue.tohill@rcm-pearls.org
Primary outcome measure(s) 21/03/2013: The previous primary outcome measures were incorrect due to an error at the time of registration. The correct primary outcome measure is as follows:
Experience of perineal pain on daily activity at 10-12 days post birth.

Previous primary outcome measures until 21/03/2013:
Women's perspectives on what they consider important in the quality and experience of their care:
1. Infection and antibiotic treatment
2. Pain
3. Healing
4. Continence
Secondary outcome measure(s) 21/03/2013: The previous secondary outcome measures were incorrect due to an error at the time of registration. The correct secondary outcome measures are as follows:
1. 10 - 12 days post birth:
1.1. severity of perineal pain
1.2. need for suture removal
1.3. use of pain relief duirng the previous 24 hours
1.4. uptake and duration of exclusive breastfeeding
1.5. perineal wound infection
2. Three months post birth:
2.1. Edinburgh Postnatal Depression Scale (EPDS [14])
score of ≥ 13
2.2 timing of resumption of intercourse
2.3. satisfaction with the perineal repair.
2.4. duration of exclusive breastfeeding

Previous secondary outcome measures until 21/03/2013:
1. Maternal physical and psychological well-being, assessed by the 10 day and 3 month questionnaires:
1.1. Incidence of perineal pain
1.2. Use of postpartum analgesia
1.3. Perineal wound infection
1.4. Uptake and duration of breastfeeding
2. Proportion of women who have an Edinburgh Postnatal Depression Scale (EPDS) score of greater than or equal to 13 at 3 months.
Sources of funding Health Foundation - Quality Improvement Initiative (UK)
Trial website http:www.rcm-pearls.org
Publications 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20184764
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24059602
Contact name Ms  Sue  Macdonald
  Address 15 Mansfield Street
  City/town London
  Zip/Postcode W1G 9NH
  Country United Kingdom
  Tel +44 (0)207 312 3468
  Fax +44 (0)207 312 3461
  Email Sue.Macdonald@rcm.org.uk
Sponsor Royal College of Midwives (UK)
  Address c/o Mrs Louise Silverton
Deputy General Secretary
15 Mansfield Street
  City/town London
  Zip/Postcode W1G 9NH
  Country United Kingdom
  Tel +44 (0)207 312 3535
  Fax +44 (0)207 312 3536
  Email louise.silverton@rcm.org.uk
  Sponsor website: http://www.rcm.org.uk
Date applied 20/08/2007
Last edited 27/09/2013
Date ISRCTN assigned 26/03/2008
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