Pre-eclampsia Pregnancy-induced hypertension Hypertensive disorders of pregnancy Pregnancy-related hypertension with proteinuria Gestational hypertension with proteinuria Eclampsia (if seizures occur) Toxemia, Pre-eclampsia
Conditions
Interventions
The intervention is an algorithm based on the urine protein/creatinine ratio (PCr) + sFlt-1/PlGF ratio, along with a telemonitoring strategy. The algorithm incorporates a PCr cut-off of 30 (mg/mmol) a
intermediate risk includes telemonitoring
high risk necessitates immediate admission.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age =16 yearsSingleton pregnancyGestational age between 20 weeks + 0 days and 36 weeks + 6 daysClinical suspicion of pre-eclampsia, defined as at least one of the following (based on ISSHP 2021 and NVOG 2019 guidelines):a. New-onset hypertension:Systolic blood pressure =140 mmHg and/orDiastolic blood pressure =90 mmHg (measured using validated equipment and standard clinical procedures)b. Worsening of pre-existing hypertension:An increase of =10 mmHg in systolic and/or diastolic blood pressure compared to baseline, orIncreased need for antihypertensive medication, as assessed by the treating physician based on clinical contextc. New-onset proteinuria, defined as:Dipstick proteinuria =2+ Note: The protein-to-creatinine ratio (PCR) is not part of the initial inclusion criteria and will be assessed after inclusion for risk stratification and care planning.d. Worsening of known proteinuria, defined as:An increase of =50% in the protein-to-creatinine ratio compared to a previous measurement Note: This applies to patients with known proteinuria (e.g., due to chronic kidney disease), where it is unclear whether the increase is due to the underlying condition or superimposed pre-eclampsia.e. Other clinical signs or symptoms suggestive of pre-eclampsia, such as:Epigastric pain (especially in the right upper quadrant)Severe oedema or sudden swelling of the face, hands, or feetHeadache or visual disturbances (e.g., blurred vision, scotomas)Sudden weight gain >1 kg per week (in the third trimester)Thrombocytopenia (platelet count <150 × 10?/L)Elevated liver enzymes (ALT >41 U/L or AST >40 U/L)(Suspected) fetal growth restriction (FGR) based on clinical or ultrasound findings
Exclusion criteria
Exclusion criteria: Subjects are excluded from participation if they meet any of the following exclusion criteria:1) Confirmed pre-eclampsia at time of enrolmentNote: Women with a confirmed diagnosis of pre-eclampsia prior to presentation are excluded. Those with initial symptoms or findings suggestive of pre-eclampsia, but without a formal diagnosis, are eligible. A diagnosis made after randomization is considered part of the clinical course and a study outcome.2) Any sFlt-1/PlGF ratio measured this pregnancy3) Previous participation in the PREPARE II study in current or prior pregnancy4) Gestational age =37 weeks5) Multiple pregnancy6) Insufficient understanding of Dutch or English language7) Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the occurrence of pre-eclampsia-related healthcare utilization in first week after testing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are maternal/perinatal adverse events, total healthcare usage, pre-eclampsia diagnosis, quality of life, and productivity losses. A cost-effectiveness analysis from a societal perspective will be performed. | — |
Countries
Netherlands
Contacts
Public ContactA Peters
Leids Universitair Medisch Centrum
Outcome results
None listed