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Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Karl Winkler, University Hospital Freiburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01967355
First Posted: October 22, 2013
Last Update Posted: June 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karl Winkler, University Hospital Freiburg
  Purpose
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 Intervention
Preeclampsia Dyslipidemia Proteinuria Hypertension Other: lipid apheresis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Resource links provided by NLM:


Further study details as provided by Karl Winkler, University Hospital Freiburg:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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). ]
  • 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). ]

Estimated Enrollment: 15
Study Start Date: April 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

Responsible Party: Karl Winkler, Professor Dr. med., University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01967355     History of Changes
Other Study ID Numbers: 2013-15
First Submitted: July 26, 2013
First Posted: October 22, 2013
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