Rotation thromboelastometry (ROTEM 'Registered Trademark') in obstetrics: baseline parameters in normal and complicated pregnancies. A prospective observational study on elective Caesarean patients.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12616000761460

Acronym

RTC (ROTEM Thromboelastometry in elective Caesarean patients)

Enrollment

206

Registered

2016-06-09

Start date

2015-09-01

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

A 3.5mL (or 7mL if complicated/high-risk for correlation with a coagulation profile) blood sample will be taken to process for a ROTEM profile, at the point of IV cannula insertion pre-operatively. No follow-up with the patient required, but medical records will be reviewed as part of data collection regarding birth outcomes (estimated blood loss, 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. Booked for an elective Caesarean section.

Exclusion criteria

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

Outcome results