APPEAL - A feasibility and pilot cluster randomised controlled trial
Research type
Research Study
Full title
Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): A feasibility and pilot cluster randomised controlled trial
IRAS ID
272603
Contact name
Debra BICK
Contact email
Sponsor organisation
Birmingham Women's and Children's NHS Foundation Trust
ISRCTN Number
ISRCTN10833250
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Pregnancy and birth are important risk factors for urinary incontinence (UI) however there is evidence that undertaking pelvic floor muscle exercises (PFME)in pregnancy reduces the likelihood of UI 3 months after birth.
NICE guidelines for antenatal care recommends midwives provide advice about PFME at woman’s antenatal visits however many pregnant women report that they do not receive sufficient information for them to perform PFME effectively.
This feasibility and pilot cluster trial is being undertaken as part of the NIHR funded APPEAL programme. Earlier studies in the programme have researched barriers and enablers to implementation of effective PFME exercises in antenatal care. This has been used to inform a training intervention for midwives to enhance PFME implementation for women under their care and the feasibility of this is being tested in this pilot cluster trial.
All 14 community midwife teams (clusters)in the two NHS trusts taking part will be randomised into ‘intervention’ or ‘usual care’ arms. Midwives in the teams in the intervention arm will be provided with a training intervention to enable and support women to undertake PFME throughout their pregnancy. All women under the care of the midwifery teams will be sent questionnaires 10-12 weeks after birth to record whether they undertook PFME, what advice they had had, how confident they were in undertaking PFME and any incontinence they experienced.
Further process and feasibility evaluation will be obtained from midwives. Those in the intervention arm will be consented and given questionnaire before and after training and those who agree will be contacted by researchers after the intervention period to obtain their views on the intervention. Some midwives in the usual care control arm will be interviewed about PFME in usual care.
This pilot will assess feasibility of a potential future definitive trial to determine effects on reducing UI after birth.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
19/WM/0368
Date of REC Opinion
3 Feb 2020
REC opinion
Further Information Favourable Opinion