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 (blood loss > 1000 ml) compared to care as usual
ID
Source
Brief title
Condition
- Other condition
- Maternal complications of labour and delivery
Synonym
Health condition
stollingsproblemen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 (blood loss > 1000 ml) compared to care as usual
Secondary outcome
1. To evaluate if controlled hypotensive resuscitation reduces transfusion
requirements.
2. To evaluate if controlled hypotensive resuscitation leads to less
coagulopathies
Background summary
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 extrapolated to pregnant women
during labor.
Study objective
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 (blood loss > 1000 ml) compared to care as usual
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 fulfil 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. Also
written informed consent will be obtained. In case of more than 500 cc blood
loss randomisation takes place. Participants will be randomised 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.
At this stage of 500-750 cc 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 2000 cc will consist of NaCl (0.9%), the additional fluid of colloids
(Voluven).
Intervention
Restrictive fluid resuscitation
Study burden and risks
Venapunction, however this is standard care in most women with post partum
hemorrhage
P. Debeyelaan 25
Maastricht 6229HX
NL
P. Debeyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
Pregnant women attending the outpatient clinic
- Pregnant and delivery/labor, > 24 weeks
- Age >= 18 years
- Informed consent
- Mentally competent, understanding Dutch language
Exclusion criteria
- 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.
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 |
|---|---|
| CCMO | NL42942.068.13 |