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Estimation of the Placental Volume by 3D Ultrasound at 12, 16 and 22 Weeks : Relation With Growth Factors and D-Dimers (VOLUPLA)
This study is currently recruiting participants.
Verified by Centre Hospitalier Universitaire de Saint Etienne, October 2008
Sponsors and Collaborators: Centre Hospitalier Universitaire de Saint Etienne
GRT : Groupe de Recherche sur la Thrombose
Information provided by: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00767182
  Purpose

Pregnancy complications called Placental Vascular Pathologies (PVP)are mainly responsible for perinatal mortality. In these cases, the placenta is smaller and often the centre of thrombotic lesions. The estimation of the placenta volume by 3D ultrasound coupled with growth factors and D-Dimers measures could improve the understanding of these pathologies to optimize their detection. Thus, the identification of predictive factors of the risk of occurrence or recurrence of PVP could allow us to propose a monitoring of patients at risk, to anticipate corticoids administration for the foetuses pulmonary maturation and perhaps later to adapt anti hypertensive and antithrombotic therapeutics.


Condition Intervention
Placental Vascular Pathologies
Other: blood sample

MedlinePlus related topics: Ultrasound
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Estimation of the Placental Volume by 3D Ultrasound at 12, 16 and 22 Weeks : Relation With Growth Factors and D-Dimers - Monocentric Prospective Cohort

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • placental volume by 3D ultrasound and D-Dimers rate [ Time Frame: 12, 16, and 22 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EPCRs rate measurements [ Time Frame: 12, 16, and 22 weeks ] [ Designated as safety issue: No ]
  • Occurrence or recurrence of PVP [ Time Frame: 12, 16 and 22 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

plasma and serum samples


Estimated Enrollment: 40
Study Start Date: August 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
pregnancy women
Other: blood sample
biological markers evaluated : D-Dimer, sEPCR

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

Inclusion Criteria:

  • previous history of one or more PVC episodes : preeclampsia, HELLPs, retroplacental hematoma, vascular IUGR<10th percentile, recurrence miscarriage >2, unexplained IUFD or IUFD after abruption placentae, eclampsia.
  • coming for a 12 weeks ultrasound

Exclusion Criteria:

  • Multiple pregnancy
  • past history of in utero fetal death due to congenital malformations, rhesus incompatibility or an infection
  • previous history of IUGR which etiology was a chromosomal, genic or infectious anomaly
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767182

Contacts
Contact: Céline Chauleur, MD 0033477828611 celine.chauleur@chu-st-etienne.fr

Locations
France
Service de Gynécologie Obstétrique - CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Céline Chauleur, MD     0033477828611     celine.chauleur@chu-st-etienne.fr    
Principal Investigator: Marie Noelle Varlet, MD            
Principal Investigator: Mireille Tronchet, MD            
Principal Investigator: Emmanuelle Denis-Bellicard, MD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
GRT : Groupe de Recherche sur la Thrombose
Investigators
Principal Investigator: Céline CHAULEUR, MD CHU de Saint-Etienne
  More Information

Responsible Party: Service de Gynécologie Obstétrique CHU de Saint-Etienne ( Céline Chauleur )
Study ID Numbers: 0808025
Study First Received: October 3, 2008
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00767182  
Health Authority: France: Direction Générale de la Santé

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
preeclampsia
eclampsia
retroplacental hematoma
vascular IUGR
IUFD
placental volume

Study placed in the following topic categories:
Hematoma
Eclampsia
Fibrin fragment D
Pregnancy toxemia /hypertension
Pre-Eclampsia
Preeclampsia

ClinicalTrials.gov processed this record on January 16, 2009