Clinical trial NCT01967355: Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
Official title: Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Dyslipidemia
Proteinuria
Hypertension
Keywords: preeclampsia
lipid apheresis
apheresis
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prolongation of pregnancy
timeFrame: 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 outcomes:
measure: Reduction of lipoprotein levels
timeFrame: 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 outcomes:
measure: Normalization of blood pressure measured in mmHg.
timeFrame: 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: Normalization of proteinuria measured in 24-h urine collection in mg/dl
timeFrame: 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).
Locations:
city: Freiburg
country: Germany
facility: Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg
state: Baden-Württemberg
Study officials:
affiliation: Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg
name: Karl Winkler, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.