Prediction of preeclampsia and adverse events

Completed

Conditions: preeclampsia
toxemia
10026908

Registration Number: NL-OMON48757

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 400

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will assess the false-negative rate when predicting the absence of<br /><br>preeclampsia within one week as the primary objective.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Thereby, safety and efficacy analysis will include the potential influence of<br /><br>the test on clinical decision making (i.e. hospitalization, home-monitoring or<br /><br>discharge). </p><br>