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

NCT00767182 | Completed

• 3 other identifiers: 08080252008-A00233-52DGS2008-0193
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Placenta Vascular Malformation

Keywords

preeclampsia; eclampsia; retroplacental hematoma; vascular IUGR; IUFD; placental volume

Outcome Measures

Primary Outcomes (1)

• placental volume by 3D ultrasound and D-Dimers rate

  Week 12

Secondary Outcomes (8)

• EPCRs rate measurements

  Week 12

• EPCRs rate measurements

  Week 16

• EPCRs rate measurements

  Week 22

• Occurrence or recurrence of PVP

  Week 12

• Occurrence or recurrence of PVP

  Week 16

Study Arms (1)

Pregnant patients with VPP antecedent

Pregnancy women consulting for an scan during their 12th week of amenorrhea at the University Hospital of Saint Etienne will be studied in this clinical trial. They have an history of VPP (Vascular Placental Pathology). They will have to give a blood sample.

Other: blood sample

Interventions

blood sample OTHER

biological markers evaluated : D-Dimer, sEPCR

Pregnant patients with VPP antecedent

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Groupe de Recherche sur la Thrombose: collaborator

Study Sites (1)

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma and serum samples

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Céline CHAULEUR, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: March 23, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)