Primary objective: To identify those groups of pregnant patients, planned to undergo cesarean delivery, who are at risk to develop severe hypotension (defined as a decrease of at least15% from the baseline tension) based on their preoperative volume…
ID
Source
Brief title
Condition
- Other condition
- Maternal complications of labour and delivery
- Obstetric and gynaecological therapeutic procedures
Synonym
Health condition
hemodynamiek
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is severe hypotension, defined as either a decline in blood
pressure of 20% ore more from the baseline, or a systolic blooed pressure below
100 mmHg.
Secondary outcome
Secondary enpoints will be the relative changes in cardiac output during volume
resuscitation.
Background summary
Delivery of the baby by caesarean section under neuraxial anesthesia (spinal or
combined spinal epidural anesthesia) is common practice around the globe.
Historically the main reason for performing neuraxial anesthesia is the high
incidence of maternal airway management complications associated with the use
of general anesthesia. Unfortunately neuraxial anesthesia has its disadvantages
as well, such as spinal hypotension due to sympathicolysis. Treatment of this
hypotension has been subject of many studies. However investigations into
strategies preventing hemodynamic instability during caesarean section are
scarce. One of the pillars of prevention is adequate risk stratification on the
development of the complication. Finding a non-invasive way to identify those
groups of patients, probably with a decreased circulatory volume leading to
more severe hypotension during caesarean section, may enable us to provide a
more *tailored* volume infusion, which is now frequently done by infusion of
Hydroxy Ethyl Starch (HES) fluids.
Study objective
Primary objective: To identify those groups of pregnant patients, planned to
undergo cesarean delivery, who are at risk to develop severe hypotension
(defined as a decrease of at least15% from the baseline tension) based on their
preoperative volume status .
Secondary objective: To determine if the anesthesia and volume resuscitation
during cesarian section results in (relative) changes in cardiac output as
determined by non-invasive cardiac output monitoring.
Study design
A prospective observational multicenter trial that will investigate the blood
volume and perform non-invasive cardiac output monitoring of patients that are
undergoing elective cesarean section
Study burden and risks
During the study all women will receive approximately 500 ml HES for volume
suppletion. However before and after the first 175 ml (Voluven) venous blood
samples will be taken (10 ml. each) from a standardly placed intravenous line.
This carries no extra risk because the infusion of HES is a standardized
treatment and no extra venous puncture is needed to draw the blood. The
individual patient will not directly benefit from the study because of its
observational nature. Possibly next generations of patients could benefit from
the results. All patients are offered information pertaining their situation
during the delivery after they have fully recovered.
P.Debyelaan 25
Maastricht 6229HX
NL
P.Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
-pregnant women scheduled for elective cesarean section
-over 18 years of age
-singleton pregnancy
-agree to participate in the study
-mastery of the Dutch language
Exclusion criteria
-under 18 years of age
-multiple pregnancy
-cardiac disease: pump failure, congenital defects with ongoing hemodynamic effects (valve dysfunction)
-refusal to participate in the study
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 | NL59618.068.17 |