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ID
Source
Brief title
Health condition
Pre-eclampsia, HELLP syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
The objective is to assess the value of a sFlt-1/PlGF ratio in the classification and treatment of patients with (suspected) preeclampsia. Therefore, we will assess the false-negative rate when predicting the absence of preeclampsia within one week as the primary objective. Thereby, safety and efficacy analysis will include the potential influence of the test on clinical decision making (i.e. hospitalization, home-monitoring or discharge).
Secondary outcome
- to evaluate the cost-effectiveness of adding the sFlt-1/PlGF ratio test to standard practice for short-term prediction of preeclampsia.
- to explore the correlation of the sFlt-1/PlGF ratio in patients with (suspected) preeclampsia and severity of preeclampsia/adverse outcomes/time to delivery
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.
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 objective
The sFlt-1/PlGF ratio test will have a false negative value in less than 5% of patients
Study design
Patients will be enrolled till a sample size of approximately 400 is achieved.
Inclusion criteria
Subjects enrolled in the study must meet the following inclusion criteria:
1) Age ≥ 16 years
2) Gestational age of from 20 weeks and 0 days
3) Signed written informed consent
4) a. Suspected preeclampsia as a protocol defined definition stated in Appendix Table 2
OR
b. Confirmed preeclampsia as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)
Exclusion criteria
Subjects will be excluded from participation if they meet any of the following exclusion criteria:
1) Insufficient understanding of Dutch language
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8308 |
| Other | METC LUMC : P17.168 |