a. To study whether a specific set of biomarkers is associated with PE with DVb. To study whether a specific set of biomarkers is predictive of PE with DV.
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Levels of biomarkers and bilateral uterine artery flow in multiples of the
median (for details see page 12 of research protocol).
Secondary outcome
Levels of biomarkers in multiples of the median (for details see page 12 of
research protocol)
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, which can cause 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.
PE has been associated with altered levels of various biomarkers, before and
after onset of clinical disease. De association of DV with biomarkers is
unknown. We hypothesize that PE with DV will be associated with a specific set
of biomarkers, both before and after onset of PE.
Study objective
a. To study whether a specific set of biomarkers is associated with PE with DV
b. To study whether a specific set of biomarkers is predictive of PE with DV.
Study design
Prospective and retrospective case controlled pilot study. Cases with PE will
be tested for blood biomakers associated with and predictive of PE. Also,
bilateral uterine artery blood flow of cases will be measured ultrasonically.
Placenta material will be analysed histologically. Lastly, blood biomarkers
will be retrospectively determined in samples from the first trimester of
pregnancy. Cases with DV will be compared to those without the lesions.
Study burden and risks
At time of admission and before delivery (for a maximum total of 5 times)
patients will undergo blood sampling and ultrasonic examination of the
bilateral 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
Patients who are admitted at Radboud University Nijmegen Medical Centre with the diagnosis of preeclampsia.
Exclusion criteria
Multiple pregnancies, signs of intra-uterine infection, chomosomal abnormalities of the fetus.
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 | NL38403.091.11 |