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Resuscitation strategy in obstetric hemorrhage.


- candidate number14194
- NTR NumberNTR3789
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jan-2013
- Secondary IDs42942 
- Public TitleResuscitation strategy in obstetric hemorrhage.
- Scientific TitleRestrictive versus massive fluid resuscitation strategy: Influence on blood loss and hemostatic parameters in obstetric hemorrhage.
- ACRONYM
- hypothesisMassive fluid resuscitation in patients with post partum hemorrhage according to current guidelines might engrave the blood loss.
- Healt Condition(s) or Problem(s) studiedCoagulation, Restritive fluid resuscitation, Post partum hemorrhage
- Inclusion criteria1. Pregnant women attending the outpatient clinic;
2. Pregnant and delivery/labor, > 24 weeks;
3. Age ≥ 18 years;
4. Informed consent;
5. Mentally competent, understanding Dutch language.
- Exclusion criteria1. 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);
3. Known congenital, coagulation disorders;
4. Pre-eclampsia (higher risk of low plasma volume, higher risk of volume overload).
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2013
- planned closingdate1-mrt-2015
- Target number of participants250
- InterventionsRestrictive fluid resuscitation: standaard care means suppletion of 1,5-2 times the amount of lost blood, in the study group 0,75-1x the amount of blood loss will be administered.
- Primary outcomeIn women with early, mild PPH (blood loss 500-750ml) we would like to establish whether controlled hypotensive resuscitation strategy reduces the progression to severe PPH compared to care as usual.
- Secondary outcome1. To evaluate if controlled hypotensive resuscitation reduces transfusion requirements;
2. To evaluate if controlled hypotensive resuscitation leads to less coagulopathies.
- TimepointsInterim analysis after 50 patients in each arm.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Natascha Lange, de
- CONTACT for SCIENTIFIC QUERIES Natascha Lange, de
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht Universitair Medisch Centrum (MUMC+)
- PublicationsN/A
- Brief summaryBackground:
Post partum hemorrhage with high maternal morbidity and mortality is an increasing problem in the Netherlands and other developed countries. Current guidelines advise massive fluid transfusion in women with post partum hemorrhage, about two times the lost amount of blood. This advice is not based on scientific evidence and could cause problems such as acidosis, edema or coagulopathies. In trauma medicine there is increasing research about restrictive fluid resuscitation. The hypothesis is to first stop the bleeding and then volume. These data however cannot be extrpolated to pregnant women during labor.

Study design:
We want to include women who have 500- 750 cc blood loss. In a general hospital population, about 15% of all women will fulfill these criteria, 5% of all women will proceed to blood loss of > 1000 cc. Since during labor informed consent cannot be obtained, all women attending the out patients clinic and who are eligible to participate in the study will be asked informed consent and written informed consent will be obtained. Randomization takes place after written informed consent is obtained. Participants will be randomized to care as usual: massive fluid resuscitation (control group) and controlled hypotensive resuscitation (study group). In women participating in the study, blood loss will be measured.
During labor, at 500-750cc blood loss the study protocol starts (T1). If not already available, an intravenous line and blood testing (Hb, Ht) is regular care. Women in the study group will be resuscitated with fluids at 0.75- 1.0 times of the estimated blood loss, women in the control group will be resuscitated with fluids 1,5-2 times the amount of blood loss. In all women the first 1000 cc will consist of NaCl (0.9%), the additional fluid Voluven./Volulyte.

Study population:
Women attending the out patients clinic in the participating hospitals.

Primary study parameters/outcome of the study:
In women with early, mild PPH (blood loss 500-750ml) we would like to establish whether restrictive resuscitation strategy reduces the progression to severe PPH compared to care as usual.
Secundary study parameters/outcome of the study:
1. To evaluate if controlled hypotensive resuscitation reduces transfusion requirements;
2. To evaluate if controlled hypotensive resuscitation leads to less coagulopathies.
- Main changes (audit trail)
- RECORD11-jan-2013 - 20-jan-2013


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