Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Prolongation of pregnancy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lipid apheresis
Lipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus.
Intervention: lipid apheresis (Other)
Outcomes
Primary Outcomes
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 Outcomes
- 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).)
Investigators
Karl Winkler
Professor Dr. med.
University Hospital Freiburg