Clinical trial NCT00485784: Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications
Official title: Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Keywords: Identify in a population of patients with a PE, an IUGR and a FD a modification of circulating endothelial biomarkers compared with normal pregnancy.
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2007-06-13
Enrollment: 280
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.
* 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

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique
city: Marseille
country: France
facility: Hôpital Nord
city: Marseille
country: France
facility: Hôpital de la Conception
city: Nice
country: France
facility: Chu Nice Hopital de L'Archet
Study officials:
affiliation: Unité Mère-Enfant Hôpital Nord 13005 Marseille - Assistance Publique Hôpitaux de Marseille
name: Florence BRETELLE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: