Primary Objective:Delineate the differences in cellular composition and function at the maternal-fetal interface in patients with SLE compared to healthy women Secondary Objectives:- Establish a novel in-vitro model to study cell-cell interaction at…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the differences in the profile and function of
stromal and immune cells from the placenta of healthy pregnancies,
uncomplicated SLE pregnancies and complicated SLE pregnancies.
Secondary outcome
A secondary study parameter is the establishment of an in vitro organoid-based
model for the maternal-fetal interface.
Background summary
Systemic lupus erythematosus (SLE) predominantly affects women during their
childbearing years, whose pregnancies are characterized by a strongly
increased risk for potentially life-threatening maternal complications (e.g.
pre-eclampsia, placental abruption) and adverse fetal outcomes (e.g. preterm
delivery, growth restriction, fetal death). This severely impacts the physical
and mental health of women with SLE and their children. To better predict and
improve the outcomes of SLE pregnancies, understanding the underlying
biological processes is essential.
Study objective
Primary Objective:
Delineate the differences in cellular composition and function at the
maternal-fetal interface in patients with SLE compared to healthy women
Secondary Objectives:
- Establish a novel in-vitro model to study cell-cell interaction at the
maternal-fetal interface
- Identify potential peripheral blood biomarkers associated with failing
maternal-fetal tolerance
Study design
This is a prospective cohort study where participants will be asked to
participate during the first trimester of pregnancy. Three times during
pregnancy, one time <48 hours before delivery, and one time after birth 45 ml
extra blood will be drawn and after birth their placenta*s will be collected.
Study burden and risks
The blood will be drawn simultaneously with the blood drawn for routine patient
care. Only if this in exceptional circumstances is not possible will there be
an additional blood collection for this study. The placenta will be collected
after birth and poses no burden for the participant. Therefore, there is
negligible extra risk of participation in this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Age 18 years or older
Antenatal care and delivery in the Department of Obstetrics and Gynecology of
Amsterdam UMC
Patients diagnosed with SLE
Signed informed consent
Exclusion criteria
Persons unable to give informed consent
Healthy controls: diagnosis with systemic inflammatory disease, or malignant
disease.
Multifetal pregnancy
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 | NL80125.018.21 |