Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000871448
Ethics application status
Approved
Date submitted
22/07/2025
Date registered
12/08/2025
Date last updated
12/08/2025
Date data sharing statement initially provided
12/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study investigating prepartum fibrinogen levels and risk of postpartum haemorrhage in pregnant people
Scientific title
A pilot study investigating prepartum fibrinogen levels and risk of postpartum haemorrhage in pregnant people
Secondary ID [1] 314969 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pregnancy 338282 0
Condition category
Condition code
Reproductive Health and Childbirth 334585 334585 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prepartum serum fibrinogen levels taken on pregnant people aged greater than or equal to 18 years old admitted to hospital for the purpose of childbirth, requiring intravenous cannula insertion as part of their standard care on admission to birth suite or theatre.
The condition is pregnant people with low prepartum fibrinogen levels (defined as serum fibrinogen 500ml). Participants will be required to consent to collection of data as well as access to medical records by research staff for relevant data collection. Participant will also be required to complete two surverys, one at day 1 post-delivery (Obs-QoR-11) and one at day 30 post-delivery (Edinburgh postnatal depression scale)
Participants will be observed from admission to discharge, with a text message follow-up survey at day 30 post-delivery
Intervention code [1] 331562 0
Early Detection / Screening
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342258 0
Incidence of postpartum haemorrhage as defined by >500ml blood loss
Timepoint [1] 342258 0
Within 24 hours post delivery of infant
Primary outcome [2] 342327 0
Feasibility of expanding the study to a larger multicentre trial
Timepoint [2] 342327 0
At the finalisation of the pilot study ~12 months post-study commencement
Secondary outcome [1] 450149 0
Severity of postpartum haemorrhage (severe PPH >1000ml)
Timepoint [1] 450149 0
Within 24 hours of delivery
Secondary outcome [2] 450150 0
ICU admission post partum
Timepoint [2] 450150 0
Admission to ICU prior to discharge from hospital post delivery
Secondary outcome [3] 450151 0
Post-delivery day 1 (POD1) fibrinogen level (to calculate % decrease from baseline) in women who experience PPH
Timepoint [3] 450151 0
24 hours post delivery
Secondary outcome [4] 450152 0
Post-delivery day 1 haemoglobin in women who experience PPH (blood loss >500ml)
Timepoint [4] 450152 0
24 hours post delivery
Secondary outcome [5] 450153 0
Blood transfusion requirement / activation of massive transfusion protocol
Timepoint [5] 450153 0
Within 72 hours postpartum
Secondary outcome [6] 450154 0
Length of hospital admission
Timepoint [6] 450154 0
At time of hospital discharge
Secondary outcome [7] 450155 0
Day 1 quality of recovery
Timepoint [7] 450155 0
Day 1 post delivery
Secondary outcome [8] 450156 0
Postpartum depression score
Timepoint [8] 450156 0
Day 30 post-partum

Eligibility
Key inclusion criteria
Pregnant people
- Age: greater than or equal to 18 years old
- Provided consent
- Has a cannula inserted for delivery
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <18 years old
Does not consent
No IV cannulation required on admission
Any patient who refuses blood products
Patients with a known fibrinogen deficiency or disorder

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The primary outcome is a quantification of the relationship between fibrinogen levels and the degree of blood loss. After testing for normality, a Pearson’s Correlation Coefficient will be used to quantify the linear relationship. If the data is not normally distributed, a Spearman’s Correlation Coefficient will be used instead. The p-value will also be calculated to determine if the correlation is statistically significant with an alpha level set at 0.05. Other secondary outcomes will also be analysed using a multivariable logistic regression analysis by a statistician.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/07/2025
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
1000
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28232 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 28233 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 44443 0
3128 - Box Hill
Recruitment postcode(s) [2] 44444 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 319523 0
Government body
Name [1] 319523 0
Eastern Health Foundation Research and Innovation Grant
Country [1] 319523 0
Australia
Primary sponsor type
Government body
Name
Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 322023 0
None
Name [1] 322023 0
Address [1] 322023 0
Country [1] 322023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318097 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 318097 0
Ethics committee country [1] 318097 0
Australia
Date submitted for ethics approval [1] 318097 0
17/01/2025
Approval date [1] 318097 0
27/02/2025
Ethics approval number [1] 318097 0
E25-001-115717

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143110 0
Dr Sarah Lee
Address 143110 0
5 Arnold Street Box Hill Hospital Eastern Health 3128 Victoria
Country 143110 0
Australia
Phone 143110 0
+61 0426690902
Fax 143110 0
Email 143110 0
[email protected]
Contact person for public queries
Name 143111 0
Sarah Lee
Address 143111 0
5 Arnold Street Box Hill Hospital Eastern Health 3128 Victoria
Country 143111 0
Australia
Phone 143111 0
+61 0426690902
Fax 143111 0
Email 143111 0
[email protected]
Contact person for scientific queries
Name 143112 0
Sarah Lee
Address 143112 0
5 Arnold Street Box Hill Hospital Eastern Health 3128 Victoria
Country 143112 0
Australia
Phone 143112 0
+61 0426690902
Fax 143112 0
Email 143112 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To maintain confidentiality no individual participant data will be shared



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    HREC E25-001-115717 Final Approval Feb2025.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.