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Table 1 Feasibility and pilot trial objectives

From: Antenatal preventative pelvic floor muscle exercise intervention led by midwives to reduce postnatal urinary incontinence (APPEAL): protocol for a feasibility and pilot cluster randomised controlled trial

• Provide training for community midwife teams randomised to the intervention arm to encourage the incorporation of a PFME care package into their usual antenatal care

• Assess if training, intervention implementation and trial processes are acceptable to midwives

• Assess if midwife characteristics (e.g. years qualified) are similar across trial arms for feasibility

• Assess questionnaire return rates from women at 10–12 weeks postpartum overall and in both trial arms to inform feasibility and estimate sample size for a full-scale RCT

Assess characteristics of women overall and within trial arms who return questionnaires compared with all those who gave birth in the same midwifery teams over the same study period but did not respond, using anonymised routine data

• Assess if baseline characteristics collected following birth (self-reported UI at pregnancy commencement, maternal and obstetric characteristics collated from antenatal booking, labour and birth data) are similar across trial arms to inform feasibility

• Assess women’s practice of PFME before, during and after pregnancy using women’s postnatal questionnaire and interview data

• Assess prevalence of UI and faecal incontinence at 10–12 weeks postpartum using women’s questionnaire data to inform the sample size calculation for a full-scale RCT

• Assess midwife support for PFME in both trial groups using qualitative interviews with midwives, women, and women’s questionnaire data to inform feasibility

• Undertake any necessary revisions to the APPEAL training package and following this, recommend roll-out by midwives to all pregnant women as part of the NHS Long-Term Plan