Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Hypertension Clinical Trial

Official title:

Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967355
• Other study ID #: 2013-15
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: May 8, 2014

Study information

• Verified date: August 2018
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 8, 2014
• Est. primary completion date: May 8, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension
• Pre-Eclampsia
• Preeclampsia
• Proteinuria

Intervention

Other:
• lipid apheresis

Locations

Country	Name	City	State
Germany	Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg	Freiburg	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Karl Winkler

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	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).
Primary	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	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).