Effect of electronic fetal monitoring method used during labour on emergency caesarean section rates: START (STan Australian Randomised Trial).

This is a 3- year randomised controlled trial (with stratification for parity) comparing STan monitoring (intrapartum electronic fetal monitoring using cardiotocography plus fetal monitoring of the ST segment of the electrocardiogram) with CTG monitoring (intrapartum cardiotocography) alone. The study will be implemented at the Women’s and Children’s Hospital (WCH), Adelaide (a Level 6 high risk specialist facility with approximately 5000 deliveries per annum). When there is clinical indication for electronic monitoring during labour for a woman who has given prior consent, randomisation to ‘STan monitoring’ or ‘CTG alone’ arms will take place with an allocation ratio of 1:1 using a web-based randomisation procedure. The electronic monitoring being assessed will take place from randomisation to the birth of the baby. The monitoring will be conducted by midwives and obstetricians who have been trained in the use of CTG and STan monitoring (holding Australian national FSEP CTG accreditation, as well as institutional in house accreditation for competency at STan interpretation). The staff will all be accredited to provide intrapartum care at the WCH (a level 6 tertiary maternity care institution). Within 2 weeks of birth, all cases and controls will be reviewed by a multidisciplinary panel of experienced clinicians to assess adherence to electronic fetal monitoring (CTG and STan) protocols and procedures. Any evidence of protocol violations will be fed back to the relevant providers to optimise protocol adherence. Protocol for STan monitoring: A STan capable monitor will be connected to a tocodynometer on a belt applied to the woman’s waist. If her membranes are ruptured, a fetal scalp electrode (scalp clip) will be applied to the occipital region of the fetal scalp, and monitoring will commence as per guidelines. If membranes are still intact, they will be artificially ruptured when it is safe and clinically appropriate, a scalp clip will be applied to the fetus, and STan monitoring commenced. If it is not possible or clinically appropriate to rupture the membranes, an external belt mounted tocodynometer and CTG doppler will be commenced (as per clinical necessity, using RANZCOG guidelines). Once clinically appropriate and safe, the membranes will be ruptured, a fetal scalp clip will be applied and STan monitoring will commence. Protocol for CTG (control) monitoring: A CTG machine in the delivery room will be activated. A belt with a tocodynometer will be applied to the woman’s waist. External monitoring of the fetal heart rate will commence by a belt mounted Doppler monitor around her waist, or if clinically indicated, a fetal scalp clip will be applied and monitoring will commence as per the RANZCOG guidelines. A psychosocial questionnaire will be sent to all randomised women approximately 7-weeks after delivery. A subset of women who respond to the psychosocial questionnaire will be asked to complete a discrete choice experiment and semi structured interview. Psychosocial questionnaire - EQ5D; general health questionnaire; Edinburgh Postnatal Depression Survey;Infant Feeding; Birth Satisfaction Survey; Monitoring response (purpose designed); trade off questions and open ended questions on positive and negative experiences. Semi structured interviews: The interviews will seek to further understand women's experiences and satisfaction with the fetal monitoring they received. When women receive the psychosocial questionnaire, they will be asked to indicated if they are interested in participating in a qualitative review. 20- to 40 women will be ended to reach saturation. Interviews will take place at a time and location to suit the women. Discrete choice experiment: Data from qualitative studies regarding STan will be used to determine the key factors or attributes related to preference. Interview data will inform the development of a subsequent preliminary survey applied to 20 women attending antenatal clinics. This will provide data to inform parameter values for the most efficient experimental design of the survey. The final Discrete Choice Experiment will be sent to all randomised women approximately 16-weeks after delivery. Sample size will depend upon the preliminary survey results, but previous work has indicated that approximately 100 in each arm should allow robust parameter estimation.