Dyslipidemia, Hypertension, Preeclampsia, Proteinuria
Conditions
Keywords
preeclampsia, lipid apheresis, apheresis
Brief summary
Preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main cause of maternal and fetal morbidity and mortality. The cause of preeclampsia is still not clear and the only therapy is preterm caesarean section. In severe preeclampsia an accumulation of triglyceride-rich lipoproteins occurs. Therefore, lipid apheresis is performed as lipid-removing therapy for treatment of preeclampsia in order to prolong pregnancy and provide the fetus more time for maturation. In this individual treatment patients with early preeclampsia (\<= 32 weeks of gestation) will be offered a H.E.L.P.-apheresis to postpone caesarean section and therefore prolong pregnancy.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* pregnant women * early preeclampsia (\< 32 week of pregnancy) * arterial hypertension during pregnancy * proteinuria (=\> 1 + dipstick or 0\> 300 mg/24h) * and/or intrauterine growth retardation (IUGR) * informed consent
Exclusion criteria
* every acute indication for immediate delivery * no informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prolongation of pregnancy | Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks). | A deteriorating clinical condition of the mother and the fetus necessitates a caesarean section (c.s.). However, if c.s. takes place too early lung maturation of the fetus may not be completed. Apheresis is initiated and will be continued until lung maturity is achieved and the clinical condition of the mother and the fetus improves. |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of lipoprotein levels | Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks). |
Other
| Measure | Time frame |
|---|---|
| Normalization of blood pressure measured in mmHg. | Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks). |
| Normalization of proteinuria measured in 24-h urine collection in mg/dl | Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks). |
Countries
Germany