The evaluation of a novel biosensor to continuously monitor human fetal scalp lactate intrapartum

Not Applicable

• Conditions: Birth asphyxia; Hypoxic ischaemic encephalopathy; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12624000925549
• Lead Sponsor: VitalTrace Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-31
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified