Rotational Thromboelastometry (ROTEM ('Registered Trademark') in obstetrics: baseline parameters in normal and complicated pregnancies. A prospective observational study on labour ward inpatients.

ROTEM ('Registered Trademark') thromboelastometry in parturients: baseline parameters in normal and complicated pregnancies.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616000760471

Acronym

RTLW (ROTEM Thromboelastometry in Labouring Women)

Enrollment

195

Registered

2016-06-09

Start date

2015-07-02

Completion date

2016-12-31

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Recruitment of parturients will occur at the Royal Brisbane and Women’s Hospital (RBWH). There is increasing use of ROTEM(TM) for point-of-care coagulation monitoring in patients with massive haemorrhage, but there still remains limited data on reference ranges in normal pregnancies and subsequently limited understanding of the effects of complicated pregnancies on ROTEM(TM) interpretation. With the recent implementation of ROTEM(TM) within the RBWH, reference ranges for the obstetric population need to be established to optimise interpretation of derived values.

Interventions

ROTEM thromboelastometry profile. A 3.5mL sample (or 7mL sample in high risk patients where coagulation profiles will be tested in addition to the ROTEM profile) will be taken at the point of venepuncture or IV cannulation when the patient is admitted to the labour ward. No follow-up required apart from data collection regarding mode of delivery, estimated blood loss and neonatal outcomes.

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Pregnant and of greater than 30 weeks gestation; in established labour

Exclusion criteria

Severe cognitive impairment, severe mental illness, moderate to severe intellectual disability

Outcome results