The main objective of this study is to analyse the effect of preeclampsia on levels of memory T cell subsets in peripheral blood.
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes of the study will be levels of memory T cell subsets. These
levels will be analysed and compared between the different population groups.
Furthermore, these levels will be compared to levels of memory T cells found in
a previous study, analysing these levels in women with uncomplicated pregnancy
.
Secondary outcome
Not applicable.
Background summary
Adaptation of the maternal immune system to accommodate the semi-allogeneic
fetus is necessary for pregnancy success. Dysregulation of this immune
adaptation is implicated in reproductive disorders as infertility, recurrent
miscarriage, fetal growth restriction, and preeclampsia. The mechanisms being
responsible for fetal tolerance are not known. Several T cell subsets have been
implicated in fetal tolerance. Interestingly, the incidence of immune related
pregnancy disorders are higher in first pregnancies. However, women with a
previous pregnancy complicated by preeclampsia have higher incidences of
preeclampsia in subsequent pregnancies. These epidemiologic findings suggest a
possible role for memory T cells. A previous study (manuscript in preparation)
indeed showed short and long term effects of pregnancy on memory T cells. The
effects of preeclampsia on memory T cells are not known. Possibly, pregnancies
complicated by preeclampsia regulate memory T cells differently than
uncomplicated pregnancy.
Study objective
The main objective of this study is to analyse the effect of preeclampsia on
levels of memory T cell subsets in peripheral blood.
Study design
This study is an observational study in which levels of memory T cells will be
analysed in 2 different groups. Peripheral blood, taken via an arm vein, will
be analysed using multicolour flowcytometry. Levels and subsets of memory T
cells will be analysed.
Study burden and risks
If possible blood samples will be taken by means of an extra blood sample taken
at a routine sampling moment or blood will be taken at an extra blood sample
moment at a suitable time point. This will not pose any risk on the
individuals. This study investigates the pregnancy related immune changes in
pregnancies complicated by preeclampsia, eventually these changes possibly are
different in preeclampsia and therefore could potentially lead to therapies.
Subjects have no direct benefits of this study.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
healthy
written informed consent
18-40 years ;Depending on the group subjects must either meet criteria 1 or 2
1. Pregnant in first pregnancy between 25-35 weeks (pregnant women) and complicated by preeclampsia
2. > 6 months after a pregnancy complicated by preeclampsia (former pregnant women)
Exclusion criteria
- smoking
- immune related disorders (other than preeclampsia)
- fever / illness within the last month
- infertility
- body mass index <18 or >30
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55954.042.15 |
| Other | Under review bij clinicaltrials.gov |