The primary endpoint will be descriptive histology on placental bed biopsies and placenta in healthy pregnant women or women with preeclampsia and/or IUGR in need of caesarean section. In particular, the study will aim to find the degree of…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the correlation between pathological score of placental bed
from pregnancies complicated by pre-eclampsia or intrauterine growth
restriction and cardiovascular health of the mother. Placental bed pathology
will be correlated to placental patholgy. De results of the pilot study will
also be included in the analysis.
Secondary outcome
- Utilize and further investigate the feasibility of our newly devised scoring
system for spiral artery pathology and the myometrium.
- Assessments of feasibility, tissue sampling quality and yield for the
detection of acute atherosis lesions in the placental bed.
- Investigate local maternal-fetal immune interactions involved in spiral
artery remodelling (flow cytometry, transciptomic, mRNA, chromatin analysis)
Background summary
There is considerable concern about the link between a cluster of pregnancy
complications initiated by vascular pathology of the placental bed spiral
arteries (pre-eclampsia and intrauterine growth restriction) and cardiovascular
risk of the mother. At present, little is known about the mechanisms underlying
abnormal vascular development and remodelling of the myometrial spiral arteries
during pregnancy. We hypothesize that shared metabolic, immunological and
vascular pathways are responsible for abnormal placentation, as well as future
cardiovascular risk of women.
Study objective
The primary endpoint will be descriptive histology on placental bed biopsies
and placenta in healthy pregnant women or women with preeclampsia and/or IUGR
in need of caesarean section. In particular, the study will aim to find the
degree of remodelling in the spiral arteries underlying placental disease as a
primary endpoint, as well as determine the prevalence of other components of
the scoring system for placental pathology. Comparison of placental (bed)
pathology and cardiovascular health determinants of the mother will be a
primary interest in this study.
Study design
Observational study (case-control setting)
Study burden and risks
Additional burden for participants will be minimal. The collection of an
additional blood sample will mostly coincide with routine sampling at the time
of caesarean section. Tissue collection from the placenta, cord blood and
placental bed biopsy collection will occur under normal caesarean anesthesia
and has previously been performed in numerous women and is considered without
any relevant risks. Also, the pilot study showed no additional risk of biopsies
being taking during cesarean section.
Lundlaan 6
Utrecht 3584EA
NL
Lundlaan 6
Utrecht 3584EA
NL
Listed location countries
Age
Inclusion criteria
Women having preeclampsia/intrauterine growth restriction in need of a caesarean section.
Women having a normal pregnancy in need of a caesarean section
Exclusion criteria
Both/Cases: In case of operative complications in terms of, for example, excessive blood loss the surgeon in charge may decide that there is no time to perform the placental biopsies. Congenital abnormalities in the foetus.
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 | NL57021.041.16 |