Data analysis

Descriptive analysis and summary statistics were used for the quantitative data generated from the case notes review. Qualitative data generated from the focus group discussions and stakeholder interviews were initially analysed separately and then combined. Triangulation of qualitative data (i.e., combining data from interviews and focus groups) in this way has been shown to enhance understanding of complex phenomena [13, 13]. Data were analysed using a thematic framework analysis appropriate to cross-disciplinary health research [18]. This adopts a deductive approach which enabled themes to be developed based on a combination of a priori research questions [19]. Thematic framework analysis is used to show presence and absence of patterns amongst different groups and does not rely on data saturation. Nevertheless, we adopted a pragmatic approach to data collection, continuing until we were satisfied enough data had been collected covering all major themes in the framework.

The thematic framework (Fig. 1) assessed three key domains, reflecting the study objectives: understanding disease burden of pre-eclampsia; current management of pre-eclampsia; and the acceptability of planned early delivery. Each of these were evaluated from a maternal perspective, an infant perspective, and a health system perspective.

Integrated summary of key themes and findings

The domains of disease burden and current management were chosen in order to explore the need for the intervention and understand the contextual factors likely to impact trial implementation. They were also considered to be important determinants of acceptability as they may influence the perceived risks and benefits that women and healthcare providers attribute to the intervention as a result of their experiences. Understanding these perceptions at an early stage of trial development was seen as an important step, not just in assessing the feasibility of the trial itself, but also the long-term feasibility of the intervention, should the main trial prove it to be effective.