All women with working knowledge of the Dutch language with severe preeclampsia, gestational age at inclusion of 27.6-33.5 weeks, singleton pregnancy, estimated fetal weight ¡Ý 500 gram and no known major fetal congenital anomalies. Ernstige preeclampsie, zwangerschapsduur 27.6-33.5 weken, geschat gewicht boven 500 gram zonder ernstige structurele afwijkingen
Conditions
Interventions
After admission for severe preeclampsia, patients will be stabilised with antihypertensive medication and magnesium sulphate and administered corticosteroids for inducement of fetal maturity according
Sponsors
Dutch consortium for studies in women's health and reproductivity.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent; 2. Working knowledge of Dutch language; 3. Gestational age 27.6 – 33.5 weeks at inclusion; 4. Estimated fetal weight ≥ 500 gram at inclusion; 5. No major fetal congenital anomalies; 6. Severe preeclampsia (modified from the criteria for severe preeclampsia (ACOG practice bulletin no. 33, table 1)): Preeclampsia (hypertension with proteinuria ≥ 0.3 g/24 hrs) and one or more of the following criteria: A. Clinical symptoms like cerebral or visual disturbances (e.g. headache) and/or right upper quadrant or epigastric pain; B. Laboratory abnormalities: thrombocytopenia (< 100 x 109/L) and/or impaired liver function tests (ASAT/ALAT ≥ 70 U/L and lactic dehydrogenase (LDH) ≥ 600 U/L) and/or haptoglobin < 0.2 g/L; C. Severe hypertension with intravenous antihypertensive medication (systolic ≥160 mmHg and/or diastolic ≥110 mmHg).
Exclusion criteria
Exclusion criteria: 1. Fetal indication for immediate delivery, ie. signs of fetal distress: Spontaneous repeated persistent unprovoked decelerations on CTG; 2. Fetal death or major fetal congenital anomalies or estimated fetal weight below 500 grams; 3. Therapy-resistant hypertension, defined as persistent blood pressure diastolic > 110 mm Hg and/or systolic > 160 mm Hg despite maximum medication according to protocol; 4. Placental abruption; 5. Clinically relevant pulmonary edema, defined as clinically relevant respiratory failure or severe respiratory distress requiring oxygen supplementation (more than 10 litres), with rales and/or pulse oximetry of <94% on room air; 6. Eclampsia; 7. (Sub)capsular liverhematoma; 8. Acute fatty liver of pregnancy; 9. Renal failure (oliguria and/or enlarged creatinine level); 10. Cerebro-vascular incident; 11. Trombo-embolism; 12. Other severe maternal complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is composite major neonatal morbidity and perinatal mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary long-term neonatal outcome is a Bailey-3 assessment at two years corrected age. The secondary short-term maternal outcome is the occurrence of major complications before and after delivery. The secondary long-term maternal outcome is persistent morbidity or death. | — |
Contacts
Public ContactEline Wilk, van de
Outcome results
None listed