Main objective of this pilot study is to investigate the placental bed histological phenotype and evaluate a scoring system for lesion characteristics of the placental bed spiral artery in pre-eclampsia and uncomplicated pregnancy. The secondary…
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 evaluation of a systematic pathologic scoring system
for placental bed lesions
Secondary outcome
The secondary endpoint is a feasibility score for placental bed biopsies.
Thirdly, vascular pathology between both groups will be compared and scored.
Also the additional value of the analysis in Southampton to the scoringsystem
will be evaluated. The future endpoint of the main study encompasses the
correlation between pathological score of placental bed from pregnancies
complicated by pre-eclampsia or intrauterine growth restriction and
cardiovascular health of the mother. Therefore samples from the pilot study
will also be used for the intended main study.
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 investigate the placental bed
histological phenotype and evaluate a scoring system for lesion characteristics
of the placental bed spiral artery in pre-eclampsia and uncomplicated
pregnancy. The secondary objectives of the pilot study will 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. With the above an initial comparison will be made of vascular
pathology of the spiral artery between women with preeclampsia and/or IUGR and
normal pregnancy. A long term objective is to investigate the correlation
between the pathological score of placental bed and subsequent cardiovascular
health of the mother 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
Utrecht 3584 EA
NL
Lundlaan 6
Utrecht 3584 EA
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 | NL38881.041.11 |