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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lipid apheresis | Experimental | Lipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lipid apheresis | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Prolongation of pregnancy | 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. | 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). |
| Measure | Description | 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). |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl Winkler, Prof.Dr.med. | Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79104 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38728925 | Derived | Winkler K, Lorey C, Contini C, Augustinski V, Putz G, Rothele E, Benner A, Fuchs H, Pecks U, Markfeld-Erol F, Kunze M. Comparison of double-filtration plasmapheresis (DFPP) versus heparin-mediated extracorporeal LDL-precipitation (HELP)-apheresis in early-onset preeclampsia. Pregnancy Hypertens. 2024 Jun;36:101128. doi: 10.1016/j.preghy.2024.101128. Epub 2024 May 9. | |
| 29540222 |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| D050171 | Dyslipidemias |
| D011507 | Proteinuria |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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). |
| Contini C, Jansen M, Konig B, Markfeld-Erol F, Kunze M, Zschiedrich S, Massing U, Merfort I, Prompeler H, Pecks U, Winkler K, Putz G. Lipoprotein turnover and possible remnant accumulation in preeclampsia: insights from the Freiburg Preeclampsia H.E.L.P.-apheresis study. Lipids Health Dis. 2018 Mar 14;17(1):49. doi: 10.1186/s12944-018-0698-4. |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |