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Completed

NCT Number: NCT01967355

Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis

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.

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Key information

Conditions

Preeclampsia Cardiovascular Diseases Dyslipidemia Dyslipidemias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Hypertension, Pregnancy-Induced Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Pre-Eclampsia Pregnancy Complications Proteinuria Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lipid apheresis

Other

Other names: H.E.L.P.-Apheresis

Primary outcomes

  1. 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

  1. 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 outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Karl Winkler

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 22, 2013
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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