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Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Primary Purpose

Preeclampsia, Dyslipidemia, Proteinuria

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
lipid apheresis
Sponsored by
Karl Winkler
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preeclampsia focused on measuring preeclampsia, lipid apheresis, apheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lipid apheresis

Arm Description

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

Outcomes

Primary Outcome Measures

Prolongation of pregnancy
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

Full Information

First Posted
July 26, 2013
Last Updated
August 7, 2018
Sponsor
Karl Winkler
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1. Study Identification

Unique Protocol Identification Number
NCT01967355
Brief Title
Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
Official Title
Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
May 8, 2014 (Actual)
Study Completion Date
May 8, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karl Winkler

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Dyslipidemia, Proteinuria, Hypertension
Keywords
preeclampsia, lipid apheresis, apheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lipid apheresis
Arm Type
Experimental
Arm Description
Lipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus.
Intervention Type
Other
Intervention Name(s)
lipid apheresis
Other Intervention Name(s)
H.E.L.P.-Apheresis
Primary Outcome Measure Information:
Title
Prolongation of pregnancy
Description
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.
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).
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
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).
Title
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).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Winkler, Prof.Dr.med.
Organizational Affiliation
Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79104
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29540222
Citation
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.
Results Reference
derived

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Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

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