None listed
Conditions
Brief summary
Women identified as having complex pregnancies are often advised to have continuous intrapartum fetal monitoring – commonly referred to as CTG monitoring. 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 during labour and her choice of position whilst giving birth. In the Australian context, this affects over half of the 310,000 women giving birth each year. However, enabling women to have mobility during labour and birth results in a shorter labour, lower likelihood of caesarean section, fewer epidurals as well as providing psychological benefits by strengthening women’s sense of choice and control. A new wireless and beltless monitoring device, the transabdominal fetal electrocardiogram (referred to herein as TAM) will be released in Australia by Philips Healthcare in early 2019. Although there is a body of international evidence supporting the safety and efficacy of the device, and it has been registered by the Therapeutic Goods Administration (TGA) for clinical use in Australia, little is known about the implementation of TAM in authentic clinical settings. To investigate this, use of the device will initially be trialled in an Australian tertiary maternity care facility. This is the first stage of a broader investigation of the impacts of TAM in clinical practice.
Interventions
Beltless TransAbdominal Monitoring (TAM) The new device enables women to have complete freedom of movement in positioning in labour and birth. TAM uses fetal electrocardiography, maternal electrocardiography and electromyography to detect fetal heart rate, maternal heart rate and uterine activity. From this data, the wellbeing of the fetus may be assessed.
The efficacy of TAM has been proven and the device is TGA approved for use in Australia. This trial aims to explore the feasibility and accep
Beltless TransAbdominal Monitoring (TAM) The new device enables women to have complete freedom of movement in positioning in labour and birth. TAM uses fetal electrocardiography, maternal electrocardiography and electromyography to detect fetal heart rate, maternal heart rate and uterine activity. From this data, the wellbeing of the fetus may be assessed. The efficacy of TAM has been proven and the device is TGA approved for use in Australia. This trial aims to explore the feasibility and acceptability of its use in an Australian clinical setting. Women will be recruited and consented in late pregnancy, prior to labour onset. The device is beltless and wireless and comprises 5 small, round adhesive sensors (similar in size to 12 lead ECG sensors). 4 sensors are placed around the umbilicus in a clockwise configuration, and one is placed above the pubic bone. A central 'pod' about the size of a matchbox is placed on the woman's umbilicus. A cover is applied magnetically to this pod, through which the signals are sent wirelessly to the CTG machine. The devices will be applied to the abdomens of participating women by the midwives employed in the birthing unit at the Royal Hospital for Women (RHW), Randwick, NSW, Australia, who are caring for the participating women in labour. The intervention will be delivered once at the onset of established labour and will be removed after the birth of the baby, to a maximum 48 hours. The intervention will take place in the birthing unit of the RHW. TAM will be applied by the midwives caring for the participating women. Women will not require information about applying the device. Women will be supervised and cared for throughout the duration of their labour and duration of use of the intervention. Intervention adherence: if the device is found to be uncomfortable or unsuitable, it will be removed and the midwife will record the reason for this.
Sponsors
University of Technology Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Singleton pregnancy Greater than 34 weeks gestation Planning a vaginal birth Deemed to require continuous monitoring during the intrapartum period, according to local clinical guidelines (NSW Health 2018) Able to read and speak English
Exclusion criteria
Women with multiple pregnancies (the TAM device is suitable only for singleton pregnancies). Women who plan to use water immersion in a pool or bath tub. Women at low risk of complications prior to the onset of labour. Women who are known to be giving birth by planned caesarean section. Women with a fetus known to be incompatible with life. Women who commence labour and give birth prior to 34 weeks gestation.
Outcome results
None listed