The main objective of this study is to analyse the effect of fetal sex on levels of T and macrophage cell subsets in decidual tissue. Secondary objectives will be to analyse differences in the effect of maternal blood stimulation by fetal leukocytes…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes of the study will be levels of T cells and macrophage cell
subsets. These levels will be analysed and compared between both groups.
Secondary outcome
Secondary outcomes will be the effects of maternal blood stimulation by fetal
leukocytes.
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, associations have been found
between fetal sex and complicated pregnancy outcomes. Male fetuses are more
often born preterm, and pregnancies with male fetuses are more often
complicated by preeclampsia and gestational diabetes mellitus. The
pathophysiological pathways responsible for these associations are not known. A
possible pathway could be fetal sex dependent maternal immune activation. In
this study we will analyse the effectsof fetal sex on the maternal immune
system.
Study objective
The main objective of this study is to analyse the effect of fetal sex on
levels of T and macrophage cell subsets in decidual tissue. Secondary
objectives will be to analyse differences in the effect of maternal blood
stimulation by fetal leukocytes of male and female fetuses.
Study design
This study is an observational study in which levels of T cells and
macrophages will be analysed. To be able to compare this effect in both
primiparous and multiparous women, both primiparous and multiparous women will
be included. Leukocytes will be derived from decidual biopts, taken from the
placenta after delivery, and will be analysed using multicolour flowcytometry
and RT-PCR. Levels and subsets of macrophages and T cells and its deriving
cytokines will be analysed. Furthermore, maternal peripheral blood will be
stimulated by fetal cord blood.
Study burden and risks
Biopsies will be taken from placental tissue after delivery. As maternal blood
will be taken during routine blood sampling before the surgery and cord blood
will be taken after fetal cord clamping this will not pose any risk on the
individuals. This study investigates the pregnancy related immune changes in
pregnancies; 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
- scheduled for caesarean section (breech position, repeat section, elective)
Exclusion criteria
- smoking
- immune related disorders
- fever / illness within the last month
- infertility treatment (ovulation induction, IVF-ICSI, intra uterine insemination)
- body mass index <18 or >30
- spontaneous start of labour
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 | NL58331.042.16 |
| Other | Under review clinicaltrials.gov |