PREdiction of Preeclampsia and AdveRse Events
Completed
- Conditions
- Pre-eclampsia, HELLP syndrome
- Registration Number
- NL-OMON29231
- Lead Sponsor
- MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method -to evaluate the cost-effectiveness of adding the sFlt-1/PlGF ratio test to standard practice for short-term prediction of preeclampsia. <br>-to explore the correlation of the sFlt-1/PlGF ratio in patients with (suspected) preeclampsia and severity of preeclampsia/adverse outcomes/time to delivery