Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Pre-Eclampsia

Treatments: Other: Blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT00485784

2006/26

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 4 patient groups

control group

Sham Comparator group

Description:

control group

Treatment:

Other: Blood test

prééclampsies group

Experimental group

Description:

prééclampsies group

Treatment:

Other: Blood test

RCIU group

Experimental group

Description:

RCIU group

Treatment:

Other: Blood test

MFIU group

Experimental group

Description:

MFIU group

Treatment:

Other: Blood test