Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications
Study Details
Study Description
Brief Summary
This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC).
The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.
We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia.
Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth.
Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.
Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate.
The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event.
The study will last 3 years. The number of patient to include is 280.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: control group control group |
Other: Blood test
Blood test
|
| Experimental: prééclampsies group prééclampsies group |
Other: Blood test
Blood test
|
| Experimental: RCIU group RCIU group |
Other: Blood test
Blood test
|
| Experimental: MFIU group MFIU group |
Other: Blood test
Blood test
|
Outcome Measures
Primary Outcome Measures
- Bring to light except the pregnancy within a population of presenting patients one EP, a RCIU and a MFIU a modification of biomarkers circulating endothéliaux with regard to the normal pregnancy. [3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
pregnant patients aged more than 18 years and more than 12 weeks of gestation for FD group, 20 weeks of gestation for PE or IUGR group , presenting either:
-
PE (arterial pressure more than 140 mm Hg and 90 mm Hg) and at least a proteinuria evaluated on stick (one point) or 300 mg/24h.
-
IUGR with biometries below 5° percentile according to the graphs of fetal echography college after 20 weeks of gestation.
-
FD after 12 weeks of gestation or with a cranio-caudal length of more than 45 mm.
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Normal pregnancy adjusted for gestational age and parity : Patient should have no cardio-vascular past with a normal complication at the inclusion time and from which pregnancy remains uneventful until the term. The onset of premature delivery, hypertension or fetal growth restriction will exclude patients from the control group.
-
social security cover
-
written informed consent
Exclusion Criteria:
-
Foetal malformation
-
APLS known
-
Set back of patient consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique | Marseille | France | 13008 | |
| 2 | Hôpital Nord | Marseille | France | 13015 | |
| 3 | Hôpital de la Conception | Marseille | France | 13385 | |
| 4 | Chu Nice Hopital de L'Archet | Nice | France |
Sponsors and Collaborators
- Assistance Publique Hopitaux De Marseille
Investigators
- Principal Investigator: Florence BRETELLE, PU-PH, Unité Mère-Enfant Hôpital Nord 13005 Marseille - Assistance Publique Hôpitaux de Marseille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2006/26