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Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

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ClinicalTrials.gov Identifier: NCT01967355
Recruitment Status : Unknown
Verified June 2015 by Karl Winkler, University Hospital Freiburg.
Recruitment status was:  Recruiting
First Posted : October 22, 2013
Last Update Posted : June 2, 2015
Sponsor:
Information provided by (Responsible Party):
Karl Winkler, University Hospital Freiburg

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.

Condition or disease Intervention/treatment Phase
Preeclampsia Dyslipidemia Proteinuria Hypertension Other: lipid apheresis Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
Study Start Date : April 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lipid apheresis
Lipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus.
Other: lipid apheresis
Other Name: H.E.L.P.-Apheresis




Primary Outcome Measures :
  1. Prolongation of pregnancy [ Time Frame: 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 Outcome Measures :
  1. Reduction of lipoprotein levels [ Time Frame: 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 Outcome Measures:
  1. Normalization of blood pressure measured in mmHg. [ Time Frame: 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). ]
  2. Normalization of proteinuria measured in 24-h urine collection in mg/dl [ Time Frame: 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). ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967355


Locations
Germany
Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg Recruiting
Freiburg, Baden-Württemberg, Germany, 79104
Contact: Karl Winkler, Prof. Dr.       karl.winkler@uniklinik-freiburg.de   
Principal Investigator: Karl Winkler, Prof. Dr.         
Sponsors and Collaborators
Karl Winkler
Investigators
Principal Investigator: Karl Winkler, Prof.Dr.med. Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karl Winkler, Professor Dr. med., University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01967355     History of Changes
Other Study ID Numbers: 2013-15
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: June 2015

Keywords provided by Karl Winkler, University Hospital Freiburg:
preeclampsia
lipid apheresis
apheresis

Additional relevant MeSH terms:
Dyslipidemias
Pre-Eclampsia
Proteinuria
Lipid Metabolism Disorders
Metabolic Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms