Clinical trial NCT00767182: Estimation of the Placental Volume by 3D Ultrasound at 12, 16 and 22 Weeks : Relation With Growth Factors and D-Dimers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Vascular Malformation
Keywords: preeclampsia
eclampsia
retroplacental hematoma
vascular IUGR
IUFD
placental volume
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Groupe de Recherche sur la Thrombose
First posted: 2008-10-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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.

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.

Eligibility 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

Primary outcomes:
measure: placental volume by 3D ultrasound and D-Dimers rate
timeFrame: Week 12
Secondary outcomes:
measure: EPCRs rate measurements
timeFrame: Week 12
measure: EPCRs rate measurements
timeFrame: Week 16
measure: EPCRs rate measurements
timeFrame: Week 22
measure: Occurrence or recurrence of PVP
timeFrame: Week 12
measure: Occurrence or recurrence of PVP
timeFrame: Week 16
measure: Occurrence or recurrence of PVP
timeFrame: Week 22
measure: placental volume by 3D ultrasound and D-Dimers rate
timeFrame: Week 16
measure: placental volume by 3D ultrasound and D-Dimers rate
timeFrame: Week 22
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Service de Gynécologie Obstétrique - CHU Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Céline CHAULEUR, MD
role: PRINCIPAL_INVESTIGATOR
References: