Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

Pre-Eclampsia Clinical Trial

Official title:

Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485784
• Other study ID #: 2006/26
• Status: Completed
• Phase: N/A
• First received: June 12, 2007
• Last updated: August 27, 2014
• Start date: July 2007

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Pregnancy Complications

Intervention

Other:
• Blood test
Blood test

Locations

Country	Name	City	State
France	Hôpital de la Conception	Marseille
France	Hôpital Nord	Marseille
France	Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique	Marseille
France	Chu Nice Hopital de L'Archet	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No