Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00485784
First received: June 12, 2007
Last updated: August 27, 2014
Last verified: August 2014
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications

Resource links provided by NLM:


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 ]

Enrollment: 280
Study Start Date: July 2007
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Hôpital de la Conception
Marseille, France, 13385
Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique
Marseille, France, 13008
Hôpital Nord
Marseille, France, 13015
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
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00485784     History of Changes
Other Study ID Numbers: 2006/26
Study First Received: June 12, 2007
Last Updated: August 27, 2014
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.

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Pregnancy Complications
Hypertension, Pregnancy-Induced

ClinicalTrials.gov processed this record on August 28, 2014