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Completed

NCT Number: NCT00767182

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Service de Gynécologie Obstétrique - CHU Saint-Etienne

Saint-Etienne, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

biological markers evaluated : D-Dimer, sEPCR

Primary outcomes

  1. placental volume by 3D ultrasound and D-Dimers rate

    Time frame: Week 12

Secondary outcomes

  1. EPCRs rate measurements

    Time frame: Week 12

  2. EPCRs rate measurements

    Time frame: Week 16

  3. EPCRs rate measurements

    Time frame: Week 22

  4. Occurrence or recurrence of PVP

    Time frame: Week 12

  5. Occurrence or recurrence of PVP

    Time frame: Week 16

  6. Occurrence or recurrence of PVP

    Time frame: Week 22

  7. placental volume by 3D ultrasound and D-Dimers rate

    Time frame: Week 16

  8. placental volume by 3D ultrasound and D-Dimers rate

    Time frame: Week 22

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • Groupe de Recherche sur la Thrombose

Registry information

Official study 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

Acronym: VOLUPLA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 6, 2008
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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