Options: An intervention development and feasibility study to predict, and provide choices for avoiding, emergency caesarean in nulliparous women.

Background: Emergency Caesarean Section (EmCS) reduces morbidity and mortality for women and their babies. Over 100,000 EmCS are carried out annually in England, and in 2020-21, 23% of nulliparous women had an EmCS. They are safe, but more risky for women and babies than a vaginal or elective Caesarean (ElCS) birth, and more expensive. Many women find EmCS stressful and are at increased risk of psychological morbidity. Women want individualised discussions to empower them to make decisions. Providing women with options to reduce EmCS could facilitate this, reduce morbidity and save money for the NHS. The Options intervention will be a digital tool to predict risk of EmCS at 36-weeks in nulliparous women, and if increased, the inbuilt communication aide will facilitate a discussion between the woman and her clinican about planning induction or ElCS at 39 weeks. Induction may reduce the chance of EmCS by upto 15%. Aim: 1) To develop the Options intervention to predict at 36-weeks nulliparous women who are at higher-risk of EmCS and offer them an induction or ElCS for 39 weeks. 2) To perform a trial to evaluate the feasibility of a multicentre randomised study assessing whether Options is a cost-effective way of reducing EmCS and improving outcomes for mothers and babies. Objectives: 1. Develop the Options prediction model. 2. Co-produce the Options intervention. 3. Undertake a cohort study with a nested feasibility trial. Methods: During the 3 workpackages, I will engage with women from a diverse range of communities to ensure that Options meets their needs. WP1: Developng the Options prediction model An externally validated tool exists to predict EmCS, combining personal data (e.g. age/height) and a 36-week fetal scan. It predicts 6% of women as high-risk (>40%) of having EmCS. I will further externally validate this model in a more recent population (Bristol) and attempt to improve performance using candidate variables from other prediction models. I will externally validate this Options model in a multi-ethnic cohort (Bradford). WP2: Co-producing the intervention To support conversations about choices, core information sets (CIS) for induction and Casarean section will be developed using a Delphi process. Risk communication tools for the CIS will be co-produced and tested via an online survey. This and the prediction model will be incorporated into a co-designed digital tool. WP3: Cohort study with nested randomised trial Five hundred nulliparous women will be recruited to have a blinded 36-week study scan, across 2 sites. This and other variables will be used to predict risk of EmCS, we expect to identifiy 30 high-risk women, who will be randomised to receive either the Options intervention or usual care. We will investigate feasibility outcomes (recruitment methods and acceptibility of study processes), clinical outcomes (morbidity, mental health, decision-making, experience and health economics), and methods to enhance recruitment. Impact & Dissemination Each WP will result in novel translational research shared via conferences and peer-reviewed papers. The Options website will feature short films, newsletters and policy briefs. This work will underpin an application for a definitive Options trial.