Clinical Trial Summary
Background: Giving birth is a critical moment for the mother and the fetus, potentially
accompanied by stress, tissue damage, cell injury, placental hypoxia and sometimes
multisystem vascular syndrome known as preeclampsia. Epidural analgesia with a local
anesthetic is a common anesthetic approach during labor. Local anesthetics inhibit the
oxidative phosphorylation and impair the synthesis of ATP, resulting in mitochondrial
dysfunction and increased reactive oxygen species. Especially when the high demand of ATP
during pregnancy cannot be reached, apoptosis will occur in an anaerobic environment. During
apoptosis the cell membrane integrity is disturbed, releasing the cytoplasm into the blood
circulation. Circulating cell-free mitochondrial DNA acts as a damage associated molecular
pattern (DAMP) by activating the innate immune system leading to inflammation. These DAMPs
are evolutionary conserved and have structural similarity to their bacterial ancestor.
Therefore, cell-free mitochondria can act as a potent agent triggering the immune system in
an autoimmune manner as well as a biomarker for cell damage and hypoxia.
Objective: The aim of this study is to investigate to role of epidural analgesia during
birth, quantifying the copy number of circulating cell-free mitochondrial DNA in maternal
serum and the placenta compared to controls. The investigators hypothesize that epidural
analgesia with a local anesthetic has an effect on cell-free mitochondrial DNA levels,
promoting the pathogenesis of ERMF and early inflammation. In addition, circulating
mitochondrial DNA could be a potent biomarker for cell damage, early placenta
hypoxia/insufficiency or preeclampsia.
Methods: For this study the investigators planned 3 groups each consisting of 15 patients.
The intervention group (group 1) will be women with vaginal delivery having epidural
analgesia and developing fever before delivery. The control group (group 2) will be women
with vaginal delivery having an epidural analgesia without developing fever before delivery.
Women with vaginal delivery without an epidural analgesia will serve as additional control
(group 3). Blood will be taken at arrival at the delivery ward and immediately after delivery
from a peripheral venous line. In addition, venous blood from the umbilical vein will be
drawn postpartum. Axillary temperature will be measured routinely using a thermometer in a
routine clinical fashion. Circulating cell-free mitochondrial DNA and other immunological
markers will be quantified in maternal and umbilical cord (fetal) serum by real time
quantitative PCR and statistical analysis will be performed by non-parametric tests.
