No registrations found.
ID
Source
Brief title
Health condition
Hemorrhage post partum
DUTCH: Haemorrhagia/Fluxus post partum
Sponsors and support
Postbus 5800
6202 AZ Maastricht
043-3874800
hcj.scheepers@mumc.nl
Intervention
Outcome measures
Primary outcome
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 outcome
To evaluate whether the results of conventional clotting test or ROTEM can predict mild or severe HPP.
Background summary
Post partum hemorrhage (PPH) is the main cause of maternal death worldwide and the main cause of severe maternal morbidity in the Netherlands. The course of PPH is unpredictable. Timely recognition and prompt intervention are crucial for successful management. Crucial prognostic factors for the severity of PPH are a delay in obstetric management and development of secondary coagulopathy. In the usual care however, results of laboratory tests may take more than 60 minutes and are non specific. Therefore only in severe cases clotting tests are done and the regular management consists of transfusion of red blood cells and fresh frozen plasma. Evaluation of the efficacy of current treatment strategies is however lacking, also because of inadequate monitoring possibilities. In cardiac and liver surgery, the use of tromboelastometry (ROTEM) is a cost effective strategy leading to more selective substitution management and less blood transfusions.
Study objective
In cardiac and liver surgery, the use of tromboelastometry (ROTEM) is a cost effective strategy leading to more selective substitution management and less blood transfusions. The method has not yet been validated for pregnant women nor are there normal values for ROTEM in pregnancy.
Study design
Gain permission from medical and ethical commision Maastricht, start trial 01-11-2010 in Maastricht and in the other centres before 01-12-2010.
Intervention
N/A
Natascha Lange, de
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3874800
natascha.de.lange@mumc.nl
Natascha Lange, de
Maastricht 6202 AZ
The Netherlands
+31 (0)43 3874800
natascha.de.lange@mumc.nl
Inclusion criteria
1. Pregnant, > 24+0 weeks;
2. Age ≥ 18 years;
3. Informed consent;
4. Mentally competent.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2407 |
| NTR-old | NTR2515 |
| Other | CCMO : ABR 32758 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |