To study the cardiovasculair effects of vasodilatation by nifedipine (Adalat gastrointestinal therapeutic system) with or without plasma volume expansion with Voluven (colloid) in women with preeclampsia
Phase 3
- Conditions
- preeclampsiatoxicosis10026908
- Registration Number
- NL-OMON29982
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 22
Inclusion Criteria
preeclampsia, gestational age 24- 34 weeks, singleton pregnancy
Exclusion Criteria
known allergy to nifedipine, known cardiovasculair or renal- or liverpathology, previous treatment with antihypertensives or tocolytics, foetal distress necessitating delivery in less than 48 uur, imminent eclampsia, no informed consent from the patient or the doctor treating the patient, multiple pregnancy, unable to take tablets
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cardiovascular variabels: systolic, diastolic and mean bloodpressure, oxygen<br /><br>saturation, pulse and cardiac output ( and the systemic vascular resistance).<br /><br>Plasmavolume-measurement.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Hemoglobin, Thrombocytes, MCV, Na, K, Urate, Urea, Kreatinine, Glucose, ALAT,<br /><br>ASAT, LDH, Calcium, albumin, Mg, haptoglobine, lactate, total proteine,<br /><br>arterial bloodgas<br /><br>Cardiotocography: baseline and variability of the fetal hart as a way of<br /><br>assessing the fetal condition.<br /><br>Echoscopic measurements: doppler pulsatility index of the uterina arteries,<br /><br>umbilical and middle cerebral arteries<br /><br>Nifedipine-serum concentrations at different times, to calculate an area under<br /><br>the curve (AUC).<br /><br>Protein-kreatinine ratio in the urine to assess proteinuria.</p><br>