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Methodology and conduct of the cluster randomised trial WP4

The Aim of Workpackage 4  to use a cluster randomised trial to evaluate the effectiveness of the intervention developed by Workpackages 2 and 3.

Objectives

1. In parallel with the design of the intervention (WP2) and the preparation of its online component (WP3), a cluster randomised trial will be designed to introduce and evaluate the clinical and cost effectiveness of the intervention in 15 maternity units in 3 countries with relatively low VBAC rates (Germany, Ireland and Italy).in a variety of maternity care settings. This will include the number of visits per woman, measurements of access to the intervention, and elements in the anxiety-reduction package. These details will influence the training needs of staff for the trial and the trial conduct, including the work to estimate the economic impact.

2. Outcomes to be measured include, where appropriate, those defined in the core outcome set for evaluations of maternity care. Morbidity data will be collected by antenatal and postnatal surveys of women.

3. Assessment of emotional well-being, feelings of anxiety, control and perception of involvement in care, measured by standardised instruments (e.g., Cambridge Worry Scale) during pregnancy and at 3 months postnatal (postal survey).

4. Intrapartum interventions, (eg, induction/augmentation of labour, epidural, CS).

5. Adherence to guidelines and practice protocols, and adherence to intervention quantity and quality, assessed by monthly audit.

6. Maternal morbidities in pregnancy, immediate postnatal period and 3 months postnatal (e.g. pain, postpartum haemorrhage, wound infection, abdominal pain, depression), measured by validated survey tool.

7. Neonatal morbidities (e.g., resuscitation, Apgar scores, admission to intensive care).

8. Other outcomes: maternal fatigue, length of hospital stay (mother & infant), readmission, infection, breastfeeding, social functioning, economic/demographic variables from hospital information systems and validated survey tool.