Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

NCT01967355 | Completed

• 1 other identifier: 2013-15
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia; Dyslipidemia; Proteinuria; Hypertension

Keywords

preeclampsia; lipid apheresis; apheresis

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (1)

• Reduction of lipoprotein levels

  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 Outcomes (2)

• Normalization of blood pressure measured in mmHg.

  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

  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).

Study Arms (1)

Lipid apheresis

EXPERIMENTAL

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

Other: lipid apheresis

Interventions

lipid apheresis OTHER

Also known as: H.E.L.P.-Apheresis

Lipid apheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• every acute indication for immediate delivery
• no informed consent

Sponsors & Collaborators

• Karl Winkler: lead

Study Sites (1)

Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Location

Related Publications (2)

• Winkler K, Lorey C, Contini C, Augustinski V, Putz G, Rothele E, Benner A, Fuchs H, Pecks U, Markfeld-Erol F, Kunze M. Comparison of double-filtration plasmapheresis (DFPP) versus heparin-mediated extracorporeal LDL-precipitation (HELP)-apheresis in early-onset preeclampsia. Pregnancy Hypertens. 2024 Jun;36:101128. doi: 10.1016/j.preghy.2024.101128. Epub 2024 May 9.

  PMID: 38728925 DERIVED

• 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.

  PMID: 29540222 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia; Dyslipidemias; Proteinuria; Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karl Winkler, Prof.Dr.med.

  Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: October 22, 2013
• Study Start: April 1, 2013
• Primary Completion: May 8, 2014
• Study Completion: May 8, 2014
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)