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

July 26, 2013
October 17, 2013
April 2013
December 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01967355 on ClinicalTrials.gov Archive Site
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 ]
Same as current
  • 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 ]
Same as current
 
Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Preeclampsia
  • Dyslipidemia
  • Proteinuria
  • Hypertension
Other: lipid apheresis
Other Name: H.E.L.P.-Apheresis
Experimental: Lipid apheresis
Lipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus.
Intervention: Other: lipid apheresis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
June 2017
December 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Germany
 
NCT01967355
2013-15
No
Karl Winkler, University Hospital Freiburg
Karl Winkler
Not Provided
Principal Investigator: Karl Winkler, Prof.Dr.med. Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg
University Hospital Freiburg
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP