ACTRN12624000925549
Not Yet Recruiting
N/A
Feasibility and reliability of a novel biosensor for continuous monitoring of fetal scalp lactate during labour and delivery: a phase 1 study
VitalTrace Pty Ltd0 sites20 target enrollmentJuly 31, 2024
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- VitalTrace Pty Ltd
- Enrollment
- 20
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Not specified
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