Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital Freiburg
Sponsor:
Information provided by (Responsible Party):
Karl Winkler, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT01967355
First received: July 26, 2013
Last updated: October 17, 2013
Last verified: October 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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). ] [ Designated as safety issue: Yes ]
    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). ] [ Designated as safety issue: No ]

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). ] [ Designated as safety issue: Yes ]
  • 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). ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Karl Winkler, Professor Dr. med., University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01967355     History of Changes
Other Study ID Numbers: 2013-15
Study First Received: July 26, 2013
Last Updated: October 17, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Freiburg:
preeclampsia
lipid apheresis
apheresis

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

ClinicalTrials.gov processed this record on October 29, 2014