Controlled hypotensive versus massive fluid resuscitation strategy: influence on blood loss and hemostatic parameters in obstetric hemorrhage
- Conditions
- stollingsproblemenbleedingPost partum hemorrhage10026906
- Registration Number
- NL-OMON47450
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 251
Pregnant women attending the outpatient clinic
- Pregnant and delivery/labor, > 24 weeks
- Age >= 18 years
- Informed consent
- Mentally competent, understanding Dutch language
- Labor < 24+0 weeks
-Prophylactic or therapeutic anticoagulant therapy (carbasalate calcium within the last 10 days or low molecular weight heparins within last 48 hours)
- Known congenital, coagulation disorders
- Pre-eclampsia
- Known contra-indications for liberal fluid management
- Proven placenta accreta/percreta or increta;In principle there are no circumstances in which women will be excluded after the study protocol has started. We will use an intention to treat analysis, so there will be no post-randomisation exclusions. In women with more than 1500 cc of blood loss the protocol massive blood loss will be followed. At that point the endpoint of the study intervention has been reached.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In women with early, mild PPH (blood loss 500-750ml) we would like to<br /><br>establish whether restrictive resuscitation strategy reduces the progression to<br /><br>severe PPH (blood loss > 1000 ml) compared to care as usual</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. To evaluate if controlled hypotensive resuscitation reduces transfusion<br /><br>requirements.<br /><br>2. To evaluate if controlled hypotensive resuscitation leads to less<br /><br>coagulopathies</p><br>