Title: Feasibility and design of a trial to determine the optimal mode of delivery in women presenting in preterm labour or with planned preterm delivery: CASSAVA
Funder: Chief Scientist Office, Scotland

Abstract: DESIGN. The study design involves a survey of current practice and clinical uncertainty, a consensus exercise, and a qualitative study of patient and clinician views (focus groups, interviews; leading to the design of a trial. SETTING. We will recruit clinicians from UK maternity hospitals and neonatal units where preterm babies are delivered /cared for, making use of our networks (labour ward leads, Preterm Birth Network, RCOG clinical study group network, British Maternal and Fetal Medicine Society members, Royal College of Midwives) to ensure wide coverage. Women will be recruited through our charity partners Tommy’s and BLISS, through social media advertisements (which we and others have previously found to be very effective in identifying volunteers) and via community routes and from NHS sites with diverging clinician views about optimal mode of delivery. STRATEGY FOR REVIEWING LITERATURE. In preparation for the full application, we started an update of the most recent literature review (November 2015). A scoping exercise identified 54 publications and 6 registered systematic review protocols. (Note, the purpose of this literature review is to determine the populations of preterm babies and the clinical scenarios where there is clinical uncertainty about the mode of delivery; not the feasibility of recruitment to a randomised trial). These clinical uncertainties will be explored in the survey and the consensus exercise; the qualitative study will then focus on willingness to recruit to / participate in a trial to address areas of clinical uncertainty. TARGET POPULATION AND INCLUSION CRITERIA. For the research question: (inclusion) women in preterm labour with a singleton or twin pregnancy, with a cephalic or breech presentation, at between 22+0 and 36+6 weeks gestation; (exclusion) women and babies for whom there is a “medical” reason to avoid labour (eg very severe growth restriction, fulminating pre-eclampsia). We will not deliberately exclude participants who have experienced adverse events as a result of the issues above (e.g. neonatal death, stillbirth) but we will be mindful of the need to manage this sensitively. For the survey and focus groups/interviews: (inclusion) clinicians who provide clinical care for such women; women who have had previous experience or are at high risk of these events. HEALTH TECHNOLOGIES BEING ASSESSED. Methods of delivery: caesarean section compared with vaginal delivery. MEASUREMENT OF COSTS AND OUTCOMES. (i) clinical uncertainties, opinion and practice and (ii) willingness to recruit to/participate in a trial to address these uncertainties (iii) outline of RCT with approximate cost. SAMPLE SIZE. Clinicians: survey at 198 UK consultant led maternity units (anticipated response rate 60%), interviews n=25. Women: focus groups n=30-60, opinion survey>200. PROJECT TIMETABLES. 6 months leading to month 0: appoint staff; complete literature review. Months 1-4: survey to establish current practice and outstanding research questions (including analysis). Months 5-9: Delphi consensus exercise, design of trial(s), mock up of trial protocol(s) and information sheets and design of vignette(s). Months 10-22: Qualitative study, data analysis. Month 23-24: report writing. EXPERTISE IN TEAM. Clinicians looking after women and babies with preterm delivery, women with experience of (or at risk of) preterm birth, qualitative researchers, evidence synthesis, clinical triallists.

Lay abstract: BACKGROUND. The HTA (who fund health research in the UK on behalf of the Department of Health and the NHS) have asked for a proposal to do some work on this topic. This research is looking at of babies and women who are in premature labour and for whom it is not known which way is the best for them to give birth: whether it is better (safer) by caesarean section (CS) or better (safer) to try and have a vaginal delivery. The first part of this research is to find out where doctors and women feel that more research on this topic is needed. The “more research” is likely to be a randomised trial, where women who are willing to take part are allocated either to a CS or to a vaginal delivery “at random” (normally by a computer programme). We can then look at the benefits and any complications in those who have a CS and compare them with those who tried to have a vaginal delivery. This information can then be used by individual women and clinicians in the future to decide which is best for them. The “at random” part is important to prevent bias, but it might reduce women’s (and clinician’s) willingness to take part in the research. So the second part of this research is to find out whether women and clinicians would be willing to take part. AIMS. We want to find out if women and their caregivers would be willing to take part in a potential future study to address this question. At the end of this research, we anticipate one of four outcomes: a) We will know the best way for women to give birth when in premature labour. b) We will have questions about the best way for some groups of women to give birth prematurely, and we have found that women (and their caregivers) would be happy to take part in a study to find the answers. c) We will have questions about the best way for some groups of women to give birth prematurely, and we have found that women (and their caregivers) would happy to take part in a study to find some but not all of the answers. d) We will have questions about the best way for some groups of women to give birth prematurely, but we have found that women (and their caregivers) would not happy to take part in a study to find the answers. WHO IS INVOLVED. This project has been designed by doctors and midwives who look after women in pregnancy (including those with preterm birth), by researchers who are used to talking to groups of people about their views, by those who conduct research, and by patient and public representatives both from formal groups (the charities BLISS and Tommy’s) and from individual women who have experienced preterm birth. DESIGN AND METHODS. (I) Survey health professionals and patients to find out what current practice is and what the questions for research are. (ii) Design a study to answer these questions. (iii) Ask women who have or may experience premature birth and health professionals what they think about the study we have designed and whether they think people would take part (iv) Finalise the design (including size and cost) of a study to answer the questions we have found. (v) Look at any existing research. WHAT WILL HAPPEN TO THE RESULTS. We will write a report, which the funder will use to decide if they want to fund the study we designed. The results will also be shared by Bliss and Tommy’s, so families and health professionals can see what we found.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH