Methods
pre-eclampsia, hypertension
PRE-ECLAMPSIA, HYPERTENSION, RECRUITMENT
This was a pilot study, cross-sectional in design, conducted within the main MOLI randomised trial to assess the feasibility and acceptability of the PaGES Index. The pilot study took place in two public hospitals in Nagpur, India. While 1,000 women were recruited to the MOLI study (helped when a third site came on stream in 2021), this pilot study involved only the first 68 participants, irrespective of randomisation arm. As part of the pilot study, a coding framework was created and analysed. This informed the data analysis plan for the main dataset.In order to assist those interested in adopting a participant-generated PREM approach, we describe the forms and the process of this pilot study, including the analysis, in some detail. The assessment of feasibility and acceptability comprised two elements. The first involved administering the PaGES Index before and after the birth to MOLI study participants. The second utilised data from an alongside qualitative study evaluating the main MOLI trial and involved a series of one-to-one interviews with study participants, and focus groups with Research Assistants (RAs) and clinicians. This second element is known as the qMOLI study.The PaGES Index study participants were women undergoing labour induction because of pre-eclampsia or hypertension at three public hospitals in Nagpur, India. The first PaGES Index was completed after recruitment to the MOLI RCT but before randomisation. Inclusion criteria included being 18 years and above, being able to give consent, having a live singleton fetus, and having no history of allergy to misoprostol or previous history of caesarean section ([Women were recruited to the qMOLI study, according to a pre-defined sampling frame aiming to incorporate different groups of women from the study; differing mode of births, parities, socioeconomic status, recruiting site. Clinicians involved in screening, recruiting, randomising, and consenting participants to the MOLI RCT were also included in the qMOLI qualitative evaluation phase.