Main objective of this pilot study is to compare vascular lesions of the placental bed spiral artery characteristics in pre-eclampsia to spiral artery samples after an uncomplicated pregnancy. Aim of the pilot study will also be to determine the…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vascular lesions will be scored according to a systematic pathologic
classification system; additional metabolic and immunological profiling of
plasma and placental samples will be performed to investigate the link between
maternal cardiovascular risks factors and vascular lesions of the placental bed
due to defective spiral artery remodelling. The latter will be obtained through
the SMART collaborative
Secondary outcome
not applicable
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
Main objective of this pilot study is to compare vascular lesions of the
placental bed spiral artery characteristics in pre-eclampsia to spiral artery
samples after an uncomplicated pregnancy. Aim of the pilot study will also be
to determine the accuracy and yield of the placental bed biopsy technique to
detect characteristic vascular lesions of spiral arteries in normal and
abnormal placentation. The aim of the main study will be to determine the link
between spiral artery vascular pathology and subsequent cardiovascular health
of the mother. Therefore all samples in the pilot study will be used in the
main study.
Study design
Observational study (case-control setting)
Study burden and risks
Additional burden for participants will be minimal, as to the collection of an
additional blood sample will coincide with routine sampling at the time of
caesarean section. Tissue collection from the placenta, cord blood and
placental bed biopsy collection has previously been performed in numerous women
and is considered without any relevant risks.
Lundlaan 6
3584 EA, Utrecht
NL
Lundlaan 6
3584 EA, Utrecht
NL
Listed location countries
Age
Inclusion criteria
Women having preeclampsia in need of a caesarean section
Women having a intra uterine growth restriction in need of a caesarean section
Women having a normal pregnancy in need of a caesarean section
Exclusion criteria
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
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 | NL37592.041.11 |