Concern has been expressed globally at rising caesarean section (CS) rates with a lack of evidence of any associated decrease in morbidity for mothers and babies, indicating that many CSs are unnecessary. Maternal mortality and severe morbidity are trebled following CS compared with vaginal birth, and neonatal respiratory distress requiring oxygen is 2-7 times more common. CS costs Euro739 (elective) or Euro1180 (emergency) more than vaginal birth. This research team have just completed testing an intervention (OptiBIRTH) designed to increase vaginal birth after caesarean section (VBAC), thus reducing repeat CS in women who had CS before. Applying such knowledge to develop a similar intervention designed to reduce the number of unnecessary CSs in Europe would have health benefits for mothers and babies.
Aim:
To develop and pilot an intervention designed to reduce overall CS rates from approximately 34% to 27%, and to test the feasibility of a larger, pan-European trial.
A pilot cluster randomised trial will be used to test an intervention designed to reduce overall CS rates in all women. This intervention will be adapted from the OptiBIRTH intervention, using information from systematic reviews of trials, and evidence-based national guidelines, aimed at reducing CS rates, and 4 focus group interviews (FGIs) with women and their partners, and 4 with obstetricians, midwives and neonatologists. Following ethical approval, two maternity units in Dublin will be randomly allocated to receive either the intervention or usual practice, and 300-400 consenting women in each unit will be recruited. Primary outcome is CS rate; other outcomes include interventions, change in women and clinicians; attitudes to CS/vaginal birth, fear of birth in women, and maternal/neonatal morbidities up to 6 months.
Mother and baby data will be collected using self-completion surveys in pregnancy and at 3 and 6 months; postnatal, and from hospital records. Surveys have been tested for validity and reliability in a large cohort study in Ireland (MAMMI study). Cost data will be collected to test the tool proposed for use in the pan-European cluster randomised trial. Analysis of FGIs will use Constant Comparative Analysis methods. Quantitative data will be analysed by intention-to-treat using inferential statistics.
