Proteomics analysis of cerebrospinal fluid to investigate brain involvement in pre-eclampsia

Pre-eclampsia (PE) is a pregnancy-specific syndrome which is associated with
severe morbidity and mortality in both mother and child. The disorder is
characterized by hypertension and proteinuria and can affect different organ
systems. In severe pre-eclampsia the brains of the mother may be affected. This
leads to serious complications such as eclampsia or brain hemorrhage. Also, it
is known that pre-eclampsia is a risk factor for the occurrence of
cerebrovascular damage in later life. Currently, it is still unknown how the
complications in the brain of women with pre-eclampsia occur and difficult to
predict which women are at higher risk of developing brain complications.

The objective of the study is to determine the protein profile of cerebrospinal
fluid of non-pregnant women using mass-spectrometry.

This study is a follow-up project on the previously performed study (LEPRA, CSF
and pre-eclampsia, MEC 2007-087). In this project cerebrospinal fluid was
collected during the spinal anesthesia procedure before caesarean section. The
mass spectrometry analysis has been completed recently. Several differences in
protein profile were found between the case and control group. To check the
effect of pregnancy on these results, we want to supplement the data with data
on the protein profile of cerebrospinal fluid of women who are not pregnant.

The study design of the LEPRA study was a case-control study. Cases
(pre-eclampsia) and controls (healthy pregnant women) were included of which
cerebrospinal fluid was collected and analyzed. Clinical information was
collected retrospectively from the patient record.

In the current follow-up study cerebrospinal fluid of non-pregnant subjects
will be collected exactly in the same manner during the spinal anesthesia
procedure for a minor surgical procedure. This minor surgery will be at the
daycare of various specialties (eg. gynecology, orthopedics, surgery,
etcetera). During the spinal anesthesia procedure 1 ml cerebrospinal fluid will
be collected in a tube.

The tubes will be labeled with a study number directly after collection and
will be centrifuged within an hour. The supernatant will be distributed over 5
labeled tubes which will be stored in -80 degrees Celsius. After inclusion of
40 samples mass spectrometry analysis will be performed.

The following study participant information which is already obtained during
the intake in regular care will be collected:
-date of birth
-any obstetric history
-relevant data from the further medical history
-details of the menstrual cycle and possibly use of oral anticonceptives.

If these data are not available in the medical records they we will ask the
study participant to tell us after the informed consent proceduring. There is
no follow-up of subjects after the collection of the data. All data are stored
under a study number and can only be seen by study staff.

Collecting 1 ml cerebrospinal fluid is a minimal burden on the patient, since
no additional interventions are needed. There is always leakage of
cerebrospinal fluid during this procedure. The only difference is that we will
wait now a few seconds longer to collect the drops in a tube.
The loss of 1 mL of cerebrospinal fluid is the only additional physical burden
to the study participant. This can lead to a small change in pressure in the
cerebrospinal fluid, which possibly could cause headache. Other complications
are not expected.