The present study intends to assess the value of a sFlt-1/PlGF ratio in the classification and treatment of patients with (suspected) preeclampsia in the Dutch obstetrical care system. The ultimate goal is to introduce a novel clinical prediction…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will assess the false-negative rate when predicting the absence of
preeclampsia within one week as the primary objective.
Secondary outcome
Thereby, safety and efficacy analysis will include the potential influence of
the test on clinical decision making (i.e. hospitalization, home-monitoring or
discharge).
Background summary
Currently, preeclampsia is diagnosed by elevated blood pressure and protein
excretion in 24-hour urine (the *gold standard*). However, the specificity and
reliability of these separate assessments to predict who will develop
preeclampsia, eclampsia, or hemolysis, elevated liver enzymes an low platelet
count (HELLP) syndrome is poor. As a consequence, women with signs and symptoms
associated with preeclampsia may be unnecessarily hospitalized for intensive
monitoring until preeclampsia is ruled out which consequentially leads to high
costs.
An imbalance of (anti)angiogenic factors, including soluble fms-like tyrosine
kinase-1 (sFlt-1) and placental growth factor (PlGF), has been found in women
with preeclampsia. In recent studies, the determination of these biomarkers in
pregnant women has shown potential value for diagnosing and predicting
preeclampsia. Predicting the absence of preeclampsia in patients with suspicion
of the disease may lead to a reduction in over-diagnosis, admission,
over-treatment and lower the costs. In England, Germany and Austria the Elecsys
sFlt-1/PlGF ratio test is already used in daily clinical practice and the test
is included in their national protocols. In the Netherlands, patients with
suspected preeclampsia can be either hospitalized or allocated to the
home-monitoring program. The adding of the sFlt-1/PlGF ratio test to daily
clinical practice could contribute to adequate decision making in the Dutch
obstetrical care system.
Study objective
The present study intends to assess the value of a sFlt-1/PlGF ratio in the
classification and treatment of patients with (suspected) preeclampsia in the
Dutch obstetrical care system. The ultimate goal is to introduce a novel
clinical prediction rule, to reduce the need for hospitalization and rule out
preeclampsia in a higher proportion of patients without compromising safety.
Study design
Observational, multicenter, non-randomized, double-blinded, prospective cohort
study
Study burden and risks
There is no direct benefit for the subjects participating in this study. Also,
the risks related to the study participation are limited: blood sampling for
experimental studies will be done when preeclampsia is suspected and will
preferably be combined with standard laboratory assessments in routine clinical
practice. Furthermore, both physician and patient will be blinded for the test
result, as study samples will be analyzed at an independent analytical
laboratory. As such, this study follows clinical practice and is explicitly
intended to not in any way direct, guide or influence clinical decision making.
Consent is requested for 20 mL extra blood donation for the study and
preservation of tissue samples of the placenta.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
1) Age * 16 years;2) Gestational age of at least 20 weeks and 0 days;3) Signed written informed consent;4) Suspected preeclampsia as a protocol defined definition , based on one or more of the following criteria:
- New onset of elevated blood pressure (BP)
- Aggravation of preexisting hypertension
- New onset of protein in urine
- Aggravation of preexisting proteinuria
- One or more other reason(s) for clinical suspicion of PE:
* PE-related symptoms: epigastric pain, excessive edema, severe swelling (face, hands, feet), headache, visual disturbances, sudden weight gain (>1 kg/week)
* PE-related findings: low platelets, elevated liver transaminases, IUGR (Intra-uterine growth restriction);OR;5) Confirmed preeclampsia as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)
Exclusion criteria
1) Insufficient understanding of Dutch language
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 | NL61917.058.17 |