None listed
Conditions
Brief summary
An interventional study to evaluate the feasibility and reliability of a novel sensor (DelivAssure) to continuously measure indicators of fetal well-being during labour and delivery, and the acceptability of the device to pregnant women and their caregivers.
Interventions
An interventional clinical study to evaluate the feasibility and reliability of a novel new biosensor called DelivAssure.
A fetal scalp electrode will be positioned on the fetal scalp during labour for women who have consented for themselves and their unborn baby to participate in the study. The scalp electrode will be positioned once cervical dilatation is sufficient for application of the DelivAssure device and remain in situ until it is removed either immediately prior to the commencement of
An interventional clinical study to evaluate the feasibility and reliability of a novel new biosensor called DelivAssure. A fetal scalp electrode will be positioned on the fetal scalp during labour for women who have consented for themselves and their unborn baby to participate in the study. The scalp electrode will be positioned once cervical dilatation is sufficient for application of the DelivAssure device and remain in situ until it is removed either immediately prior to the commencement of skin prepping at Caesarean Section of following crowning of the fetal head in the event of a vaginal birth. Timing of application and removal of the DelivAssure device will be documented in medical records and on the case report form (CRF), including reasons for removal of the device. The fetal scalp electrode will continuously measure and record a signal that will provide information on fetal heart rate and fetal scalp lactate. The current measurement will be correlated with lactate measurement obtained from a fetal blood sample during labour and also from the umbilical cord at birth. The fetal heart rate recorded from the sensor will be correlated to any fetal heart rate monitoring obtained for clinical reasons. The information recorded by the device will not be provided to clinicians or study participants and will not be used to influence clinical management. Clinicians (medical or nursing obstetric staff) trained in application of the study device and with prior experience applying a fetal scalp electrode will be responsible for application of the study device to the fetal scalp. Non-clinical research personnel will be present to monitor the signal. Photographs will be obtained of the fetal scalp after delivery and at 4-6 week follow-up Study participants will be asked to participate in a qualitative interview conducted at 4-6 week intervals.
Sponsors
VitalTrace Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Participant 1. Informed written consent, confirmed verbally on admission to Birthing Unit 2. Cervical dilatation sufficient for application of DelivAssure device 3. Established labour 4. Uncomplicated term pregnancy 5. Rupture membranes with clear amniotic fluid 6. No concern over fetal welfare 7. Vaginal birth anticipated Clinician 1. Involvement in caring for a woman/fetus participating in the FILM1 study 2. Attendance at a focus group or individual interview
Exclusion criteria
Participants 1 Anticipated birth within 60 minutes 2. Requirement for fetal scalp clip for fetal monitoring 3. Maternal infections: HIV, Hepatitis C, Hepatitis B positive, Group B streptococcus positive, history of Herpes Simplex Type II 4. Clinical chorioamnionitis as evidenced by maternal temperature >37.50C an/or fetal baseline heart rate >180bpm and/or offensive smellingamniotic fluid 5. Proven or suspected fetal bleeding disorder 6. Prolonged rupture of the membranes (over 12 hours) Clinicians - no exclusion criteria
Outcome results
None listed