None listed
Conditions
Brief summary
For women with a BMI>40, or a BMI 30-40 and one or more comorbidities, continuous electronic fetal monitoring via cardiotocograph (CTG) monitoring, is recommended (RANZCOG 2019). Conventional forms of CTG monitoring require the labouring woman to wear two tight elastic belts around her abdomen and to be tethered to a machine by wiring, thus restricting her mobility. A wireless and beltless monitoring device, the non-invasive fetal electrocardiogram (NIFECG) was registered by the Therapeutic Goods Administration (TGA) for clinical use in Australia in 2018. The aim of this study is to determine how the use of an innovative monitoring technology, NIFECG, in women with increased BMI, compares with the current standard monitoring, CTG in: • Detection of fetal distress requiring intervention • Fetal scalp electrode (FSE) use • Maternal feelings of control and agency during labour and birth • Capacity for midwives to provide woman-centred care. Using the results of both the quantitative and qualitative data that will be collected, the study will also explore barriers and facilitators to implementation of the NIFECG as routine care for women with increased BMI. Hybrid RCT Type 1 methodology, following the approach of Curran et al. (2012), uses a hybrid effectiveness-implementation typology. The study design therefore enables a dual focus a priori, testing the effectiveness of a clinical intervention on specified outcomes whilst also synthesising implementation needs. The RCT will be conducted at three clinical sites in Australia. The sample size is 450 women.
Interventions
Participants will be randomised with consent to either the standard care for fetal monitoring cardiotocograph or the non invasive fetal electrocardiogram (NIFECG). Participants will be monitored throughout labour with the device to which they have been randomised. Midwives at the site will deliver the intervention once in each participant's labour. The time period depends on the length of time it takes each woman to give birth. This is impossible to predict but may last anything from 1 minute to
Participants will be randomised with consent to either the standard care for fetal monitoring cardiotocograph or the non invasive fetal electrocardiogram (NIFECG). Participants will be monitored throughout labour with the device to which they have been randomised. Midwives at the site will deliver the intervention once in each participant's labour. The time period depends on the length of time it takes each woman to give birth. This is impossible to predict but may last anything from 1 minute to 18 hours. The intervention occurs in the hospital labour wards of the clinical sites. The key differences in the two devices are the wearables and in the way the data is retrieved. CTG involves the woman wearing two elastic belts, to each of which a transducer is attached. One is an ultrasound transducer that measures fetal herat via sound waves. The other is a tocodynamometer that measures the pressure of uterine contractions. CTG image is at http://www.mvb-med.ch/Philips_CTG_Avalon_fm30-fr.html NIFECG uses fetal ECG, maternal ECG to collect data on fetal and maternal heart rates. It also uses electromyography to collect data on uterine contractions by picking up electrical signals from the myometrium. NIFECG image is at https://www.philips.com.au/healthcare/product/HC866488/avalon-beltless-fetal-monitoring-solution
Sponsors
University of Technology Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
BMI of 40 or above, or BMI of 35 or above in the presence of one or more co-morbidities Equal to or greater than 34 weeks gestation at the time of recruitment Equal to or greater than 36 weeks at onset of labour Planning a vaginal birth Able to read and speak English – (this study does not have adequate budget or resources to develop multi-lingual consent and information sheets or to provide interpreters at interviews).
Exclusion criteria
Women with a multiple pregnancy (the device is suitable only for singleton pregnancies). Women who are not being continuously monitored. Women who are known to be giving birth by planned caesarean section (as labour and continuous monitoring are not applicable). Women with a fetus known to be incompatible with life (as this clinical circumstance brings added burden to the woman, her family and caregivers and is beyond the scope of this study). Women who commence labour and give birth prior to 36 weeks’ gestation (as the device is not registered for use in women of less than 36 weeks’ gestation)
Outcome results
None listed