Estimation of the Placental Volume by 3D Ultrasound at 12, 16 and 22 Weeks : Relation With Growth Factors and D-Dimers

Placenta Vascular Malformation Clinical Trial

— VOLUPLA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767182
• Other study ID #: 0808025
• Secondary ID: 2008-A00233-52DG
• Status: Completed
• Phase: N/A
• First received: October 3, 2008
• Last updated: March 22, 2016
• Start date: August 2008
• Est. completion date: August 2009

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

Pregnancy complications called 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Placenta Vascular Malformation
• Vascular Malformations

Intervention

Other:
• blood sample
biological markers evaluated : D-Dimer, sEPCR

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique - CHU Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Groupe de Recherche sur la Thrombose

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	placental volume by 3D ultrasound and D-Dimers rate		Week 12	No
Secondary	EPCRs rate measurements		Week 12	No
Secondary	EPCRs rate measurements		Week 16	No
Secondary	EPCRs rate measurements		Week 22	No
Secondary	Occurrence or recurrence of PVP		Week 12	No
Secondary	Occurrence or recurrence of PVP		Week 16	No
Secondary	Occurrence or recurrence of PVP		Week 22	No
Secondary	placental volume by 3D ultrasound and D-Dimers rate		Week 16	No
Secondary	placental volume by 3D ultrasound and D-Dimers rate		Week 22	No