PREdiction of Preeclampsia and AdveRse Events

Assessment of the value of a sFlt-1/PlGF ratio test in the classification and treatment of patients with (suspected) preeclampsia in the Dutch obstetrical care system

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29231

Enrollment

400

Registered

2019-11-07

Start date

2017-12-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia, HELLP syndrome

Interventions

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria: Subjects will be excluded from participation if they meet any of the following exclusion criteria: 1) Insufficient understanding of Dutch language

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
- 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	—

Contacts

Public ContactMerlijn Wind

Leiden University Medical Center

m.wind@lumc.nl63295

Outcome results