Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

NCT ID: NCT01967355

Last Updated: 2018-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-05-08

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.

Detailed Description

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Conditions

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Preeclampsia Dyslipidemia Proteinuria Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lipid apheresis

Lipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus.

Group Type EXPERIMENTAL

lipid apheresis

Intervention Type OTHER

Interventions

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lipid apheresis

Intervention Type OTHER

Other Intervention Names

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H.E.L.P.-Apheresis

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karl Winkler

OTHER

Sponsor Role lead

Responsible Party

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Karl Winkler

Professor Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karl Winkler, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg

Locations

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Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 38728925 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29540222 (View on PubMed)

Other Identifiers

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2013-15

Identifier Type: -

Identifier Source: org_study_id

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