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A pilot study investigating prepartum fibrinogen levels and risk of postpartum haemorrhage in pregnant people

A pilot study investigating prepartum fibrinogen levels and risk of postpartum haemorrhage in pregnant people

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625000871448
Enrollment
16
Registered
2025-08-12
Start date
2025-07-09
Completion date
2026-06-01
Last updated
2025-09-08

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 pilot study will assess the feasibility of a larger multicenter study to evaluate the association between a pregnant patient’s fibrinogen level on admission to hospital for labour and their risk of major bleeding (postpartum hemorrhage). Participants will be enrolled and consented in the antenatal clinic by trained research assistants. When the participant presents to hospital in labour, and routine intravenous access is inserted, a baseline fibrinogen level will be taken. This result will be blinded to both patient and treating clinician for three days after it is taken unless it produces a grossly abnormal result (fibrinogen <1.5g/L). All participants will be followed up to determine if they have a postpartum haemorrhage, the extent of haemorrhage, its clinical management and impact on the participant. If the pilot study is successful, the purpose of the multicenter study is to evaluate if fibrinogen levels can be used as a novel predictor of postpartum haemorrhage. Furthermore data from this pilot study can be used to inform our current practice regarding postpartum haemorrhage, and to improve our current management, if required.

Interventions

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 relev

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

Sponsors

Eastern Health
Lead SponsorGovernment body

Eligibility

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

Inclusion criteria

Pregnant people - Age: greater than or equal to 18 years old - Provided consent - Has a cannula inserted for delivery

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026