Primary objective:To demonstrate elevated numbers of CEC in clinically symptomatic patients with severe preeclampsia.Secondary objectives:- To analyze the relation of CEC levels with organ damage and dysfunction. - To analyze the relation of CEC…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter:
CEC levels in patients with severe preeclampsia
Secondary outcome
Secondary study parameters
- To analyze the relation of CEC levels with organ damage and dysfunction.
- To analyze the relation of CEC levels with clinical parameters as
bloodpressure and proteinuria.
- Correlation between CEC levels and levels of circulating thrombomodulin and
other soluble markers like endoglin and e-selectin.
Background summary
The key role in the pathogenesis of severe preeclampsia is generalized
endothelial dysfunction. Circulating endothelial cells are a promising marker
of vascular injury in various diseases. Given the potential of CEC as marker
and the great need for such markers in the management of severe preeclampsia,
the role of CEC in preeclampsia should be defined.
Study objective
Primary objective:
To demonstrate elevated numbers of CEC in clinically symptomatic patients with
severe preeclampsia.
Secondary objectives:
- To analyze the relation of CEC levels with organ damage and dysfunction.
- To analyze the relation of CEC levels with clinical parameters as
bloodpressure and proteinuria.
- Correlation between CEC levels and levels of circulating thrombomodulin and
other soluble markers like endoglin and e-selectin.
Study design
Description: Case-control pilot study
Duration: January 2008 till May 2008.
Setting: Department of Obstetrics Erasmus MC, Rotterdam. A total of fifteen
women with severe preeclampsia and fifteen healthy pregnant controls will be
askes to participate in this study. In clinical patients two extra tubes of
blood will be sampled on the occasion of blood sampling. In the control group
blood samples will be drawn on an extra occasion.
Criteria for the diagnosis severe preeclampsia:
Criteria published in the protocol on page 8, criteria conform ACAG standards
Parameters that will be noted:
- maternal age, length, weight
- bloodpressure
- laboratory parameters: Hb, Ht, reticulocytes, thrombocytes, ureum, creatinin,
uric acid, total bilirubin, sodium, potassium, calcium, magnesium, total
protein, albumin, haptoglobulin, ASAT, ALAT, LDH and γGT.
- medication
Study burden and risks
The risks of participation are minimal in both groups.
Dr. Molewaterplein 60
3015 GJ Rotterdam
Nederland
Dr. Molewaterplein 60
3015 GJ Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
Case group:
- diagnosis of severe preeclampsia based upon the ACOG criteria
- written informed consent
Control group:
- ASA class I pregnant patients visiting our out-patient clinic
- written informed consent
Exclusion criteria
Control group:
- ASA class II or more
- previous pregnancies with placental syndromes as preeclampsia, growth retardation and/or gestational diabetes
- placental syndrome during the index pregnancy
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 | NL21658.078.08 |