ROTEM pilot study: A new method for measuring coagulation problems in women during labor.

The use of thromboelastometry (ROTEM®) during labor: The development of norm- and cut off values in the prediction and management of post partum hemorrhage. A pilot study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20305

Enrollment

200

Registered

2010-09-18

Start date

2010-11-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Hemorrhage post partum DUTCH: Haemorrhagia/Fluxus post partum

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant, > 24+0 weeks; 2. Age ≥ 18 years; 3. Informed consent; 4. Mentally competent.

Exclusion criteria

Exclusion criteria: 1. Labor < 24+0 weeks; 2. Prophylactic or therapeutic anticoagulant therapy (carbasalate calcium within the last 10 days or low molecular weight heparins within last 48 hours).

Design outcomes

Primary

Measure	Time frame
1. To obtain normal 'clotting' values through ROTEM® ante partum and in the post partum period; 2. To validate these clotting values for pregnant women using conventional clotting tests as golden standard.	—

Secondary

Measure	Time frame
To evaluate whether the results of conventional clotting test or ROTEM can predict mild or severe HPP.	—

Contacts

Public ContactNatascha Lange, de

Postbus 5800

natascha.de.lange@mumc.nl+31 (0)43 3874800

Outcome results