Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications - Full Text View

Sponsored by:	Assistance Publique Hopitaux De Marseille
Information provided by:	Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:	NCT00485784

Purpose

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	Intervention
Pre-Eclampsia	Other: Blood test

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
Official Title:	Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

Further study details as provided by Assistance Publique Hopitaux De Marseille:

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	July 2007
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
control group: No Intervention control group	Other: Blood test Blood test
prééclampsies group: No Intervention prééclampsies group	Other: Blood test Blood test
RCIU group: No Intervention RCIU group	Other: Blood test Blood test
MFIU group: No Intervention MFIU group	Other: Blood test Blood test

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485784

Contacts

Contact: Florence BRETELLE, PU-PH

+ 33 4 91 96 46 70

florence.bretelle@mail.ap-hm.fr

Locations

France
Hôpital de la Conception	Not yet recruiting
Marseille, France, 13385
Contact: Marc GAMERRE, PU-PH + 33 4 91 38 37 91 Marc.gamerre@ap-hm.fr
Sub-Investigator: Aubert AGOSTINI, PH
Sub-Investigator: Hélène HECKENROTH, PH
Sub-Investigator: Chafika MAZOUNI, PH
Sub-Investigator: Blandine COURBIERE, CCA
Sub-Investigator: Marianne CAPELLE, PH
Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique	Not yet recruiting
Marseille, France, 13008
Contact: Alain PASCAL, Chef de Service + 33 4 91 78 21 21 apascal@hopital-saint-joseph.fr
Sub-Investigator: Véronique ROBERT, Gynécologue
Hôpital de L'Archet 2	Not yet recruiting
Nice, France, 06202
Contact: André BONGAIN, PU-PH + 33 4 92 03 61 05 bongain.a@chu-nice.fr
Sub-Investigator: Sophie LOIZEAU, PH
Sub-Investigator: Cynthia TRASTOUR, CCA
Hôpital Nord	Recruiting
Marseille, France, 13015
Contact: Florence BRETELLE, PU-PH + 33 4 91 96 46 70 florence.bretelle@mail.ap-hm.fr
Sub-Investigator: Léon BOUBLI, PU-PH
Sub-Investigator: Claude D'ERCOLE, PU-PH
Sub-Investigator: Cécile CHAU, PH
Sub-Investigator: Laurence PIECHON, PH
Sub-Investigator: Raoul DESBRIERE, PH
Sub-Investigator: Raha SHOJAI, PH
Sub-Investigator: Anne-Sophie MAISONNEUVE, CCA
Sub-Investigator: Séverine PUPPO, CCA
Sub-Investigator: Anne-Laure RIGOUARD, CCA
Sub-Investigator: Jérémie DE TROYER, CCA
Sub-Investigator: Valérie ZARKA, PH
Sub-Investigator: Fabrice FRANCHI, CCA

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

More Information

Responsible Party:	Direction de la recherche ( Assistance publique hopitaux de marseille )
Study ID Numbers:	2006/26
Study First Received:	June 12, 2007
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00485784
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique Hopitaux De Marseille:

Identify in a population of patients with a PE, an IUGR and a FD a modification of circulating endothelial biomarkers compared with normal pregnancy.

Study placed in the following topic categories:

Hypertension, Pregnancy-Induced
Pregnancy Complications
Eclampsia
Pregnancy toxemia /hypertension

Pre-Eclampsia
Preeclampsia
Hypertension

ClinicalTrials.gov processed this record on January 16, 2009