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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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN28960026 |
| Date ISRCTN assigned | 26/03/2008 |
| Local reference number(s) | 07/MRE12/2 |
| 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 - PErineal Assessment and Repair Longitudinal Study |
| Disease/condition/study domain | Perineal trauma |
| 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. |
| Design/methodology | Randomised controlled trial using a matched pair cluster design. Maternity units are the unit of randomisation. |
| Research ethics review | Thames Valley Research Ethics Committee, University of Reading. Approved in February 2007. |
| Countries of trial | United Kingdom |
| 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 |
| Patient information material | Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet. |
| Anticipated start date | 01/12/2005 |
| Anticipated end date | 01/02/2009 |
| Status of trial | Ongoing |
| 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) | 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) | 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. |
| Trial website | http:www.rcm-pearls.org |
| Sources of funding | Health Foundation - Quality Improvement Initiative (UK) |
| Sponsor name | Royal College of Midwives (UK) |
| Sponsor details | c/o Mrs Louise Silverton Deputy General Secretary 15 Mansfield Street London United Kingdom W1G 9NH |
| Sponsor telephone | +44 (0)207 312 3535 |
| Sponsor fax | +44 (0)207 312 3536 |
| Sponsor email | louise.silverton@rcm.org.uk |
| Sponsor website | http://www.rcm.org.uk |
| Contact name | Ms Sue Macdonald |
| Contact details | 15 Mansfield Street London United Kingdom W1G 9NH |
| Contact telephone | +44 (0)207 312 3468 |
| Contact fax | +44 (0)207 312 3461 |
| Contact email | Sue.Macdonald@rcm.org.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN28960026 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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