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Benefits of Analysing Brain Biomarkers in perinatal care: a prospective observational cohort study

Benefits of Analysing Brain Biomarkers in perinatal care: a prospective observational cohort study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622001241729
Acronym
BABBies
Enrollment
110
Registered
2022-09-14
Start date
2022-10-24
Completion date
2022-12-12
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a prospective observational cohort study of 110 participants who are presenting to Royal Prince Alfred Hospital for delivery of a baby. The primary objective of this study is to determine feasibility data on collecting and testing cord blood. Secondary objectives include determining normal ranges for blood biomarkers, assessing brain biomarkers against antenatal, perinatal and postnatal complications and outcomes and assessing additional risk factors on the brain biomarker values. Three millilitres of cord blood will be collected in addition to the standard cord blood collection following clamping and cutting of the umbilical cord by the midwives. The cord blood will be spun into plasma aliquots and sent to an external laboratory for analysis of inflammatory brain biomarkers- Neurofilament light and tau (a phosphoprotein). Research staff will collect health information from the antenatal record, labour record and postnatal progress notes. Analysis of the brain biomarkers and health data will take place once samples are sent for analysis.

Interventions

We will prospectively collect umbilical 3ml of cord blood from 110 placentae. Umbilical cord blood samples will be collected by midwives in theatre or the birthing suite. All patients giving birth will be eligible for inclusion in the study. The exclusion of specific patients (e.g., category 1 emergency caesarean cases) may be at the discretion of the midwife, if collection of umbilical cord blood samples is not feasible. Cord blood required for standard of care testing of rhesus and blood gas a

We will prospectively collect umbilical 3ml of cord blood from 110 placentae. Umbilical cord blood samples will be collected by midwives in theatre or the birthing suite. All patients giving birth will be eligible for inclusion in the study. The exclusion of specific patients (e.g., category 1 emergency caesarean cases) may be at the discretion of the midwife, if collection of umbilical cord blood samples is not feasible. Cord blood required for standard of care testing of rhesus and blood gas analysis will be taken as a priority. Only once the required sample volume for this purpose has been obtained will the additional blood for this study be collected. Cases where the patient was consent but an adequate sample of blood was not able to be taken, for whatever reason, will be recorded. Blood will be stored by the midwives in the fridge in a labelled box, for later collection by a member of the Department of Anaesthetics. Biospecimens will be sent to an external lab for analysis.

Sponsors

The University of Sydney
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Planned delivery at RPAH Any route of delivery (vaginal delivery or elective/emergency caesarean sections) Willingness to provide informed consent English speaking to permit informed consent

Exclusion criteria

Expected infeasibility of sample collection (at midwife’s discretion) Non-English speaking Participants with a history of a psychological illness or other conditions which may interfere with their ability to understand the study requirements or provide consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026