Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Study Overview
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Brief Summary
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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.

Official Title
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Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Conditions
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Preeclampsia, Dyslipidemia, Proteinuria, Hypertension

Intervention / Treatment
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* Other: lipid apheresis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lipid apheresis<br>Lipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus. | Other: lipid apheresis<br> <br> * Other names: H.E.L.P.-Apheresis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 

Secondary Outcome Measures

| Outcome Measure | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preeclampsia, lipid apheresis, apheresis