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

March 22, 2016 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Service de Gynécologie Obstétrique - CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
biological markers evaluated : D-Dimer, sEPCR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
placental volume by 3D ultrasound and D-Dimers rate
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
EPCRs rate measurements
Time Frame: Week 12
Week 12
EPCRs rate measurements
Time Frame: Week 16
Week 16
EPCRs rate measurements
Time Frame: Week 22
Week 22
Occurrence or recurrence of PVP
Time Frame: Week 12
Week 12
Occurrence or recurrence of PVP
Time Frame: Week 16
Week 16
Occurrence or recurrence of PVP
Time Frame: Week 22
Week 22
placental volume by 3D ultrasound and D-Dimers rate
Time Frame: Week 16
Week 16
placental volume by 3D ultrasound and D-Dimers rate
Time Frame: Week 22
Week 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Groupe de Recherche sur la Thrombose

Investigators

  • Principal Investigator: Céline CHAULEUR, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 3, 2008

First Posted (Estimate)

October 6, 2008

Study Record Updates

Last Update Posted (Estimate)

March 23, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0808025
  • 2008-A00233-52 (Other Identifier: ANSM)
  • DGS2008-0193 (Other Identifier: DGOS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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