Storage of blood samples, placental material and ultrasonic measurements to be used in a future study the prediction of PE and DV.
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The aim of this study is storage of material and ultrasonic data. Subsequently,
a larger study will be designed aimed to develope a tool for the prediction of
preeclampsia and decidual vasculopathy. In this future study, the parameters
will be levels of biomarkers and measurements of uterine artery flow.
Secondary outcome
Not applicable.
Background summary
Preeclampsia (PE) is a hypertensive disease of pregnancy of unknown etiology,
defined by (the onset of) high blood pressure and proteinuria after 20 weeks of
gestation, causing serious maternal and fetal morbidity. Decidual vasculopathy
(DV) is a pathological finding of spiral arteries seen in PE. We previously
showed an association of DV with disease severity and fetal outcome in PE. We
concluded that PE with DV could represent a subclass of severe, early disease,
with possibly a unique underlying disease process. The prediction of PE would
enable closer monitoring and preventive interventions for high risk patients.
Various biomarkers have been found to be associated with the development of PE,
however, so far no single biomarker has been found to have a sufficient
predictive power. We hypothesize that PE can be optimally predicted using a
specific combination of biomakers. The prediction of PE with DV has not been
studied. We hypothesize that DV will be associated with a specific set of
biomarkers for the prediction of PE.
Study objective
Storage of blood samples, placental material and ultrasonic measurements to be
used in a future study the prediction of PE and DV.
Study design
Blood samples will be drawn and stored. Additionally, uterine artery blood flow
will be measured ultrasonically. Measurements will take place in first and
second trimester; peripartum and after onset of clinical disease in cases that
develop preeclampsia. After delivery, placental material will be sampled and
stored.
Study burden and risks
Pregnant women at 11-13 weeks GA, at 18-22 weeks GA, at time of development of
PE (if applicable) and before delivery (for a maximum total of 5 times) will
undergo blood sampling and ultrasonic examination of the uterine artery flow.
30-40 ml of blood will be drawn per sampling. After delivery, placental
material will be sampled for histological analysis.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Adult pregnant women at 11-13 weeks gestational age
Exclusion criteria
Multiple pregnancies, cases with intra-uterine infections, cases with chromosomal abnormalities of the fetus (determined by karyotype, diagnostics will not be performed as part of this study)
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 | NL37724.091.11 |