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Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01967355
Enrollment
6
Registered
2013-10-22
Start date
2013-04-30
Completion date
2014-05-08
Last updated
2018-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypertension, Preeclampsia, Proteinuria

Keywords

preeclampsia, lipid apheresis, apheresis

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.

Interventions

Sponsors

Karl Winkler
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Prolongation of pregnancyMother 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

MeasureTime frame
Reduction of lipoprotein levelsMother 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

MeasureTime frame
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/dlMother 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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026