|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 April 2016 |
|
Main ID: |
NCT00767182 |
|
Date of registration:
|
03/10/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Estimation of the Placental Volume by 3D Ultrasound at 12, 16 and 22 Weeks : Relation With Growth Factors and D-Dimers
VOLUPLA |
|
Scientific 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 |
|
Date of first enrolment:
|
August 2008 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00767182 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Céline CHAULEUR, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU de Saint-Etienne |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Placenta Vascular Malformation
|
|
Intervention(s)
|
|
Other: blood sample
|
|
Primary Outcome(s)
|
|
placental volume by 3D ultrasound and D-Dimers rate
[Time Frame: Week 12]
|
|
Secondary Outcome(s)
|
|
Occurrence or recurrence of PVP
[Time Frame: Week 22]
|
|
placental volume by 3D ultrasound and D-Dimers rate
[Time Frame: Week 16]
|
|
Occurrence or recurrence of PVP
[Time Frame: Week 12]
|
|
EPCRs rate measurements
[Time Frame: Week 12]
|
|
Occurrence or recurrence of PVP
[Time Frame: Week 16]
|
|
EPCRs rate measurements
[Time Frame: Week 16]
|
|
EPCRs rate measurements
[Time Frame: Week 22]
|
|
placental volume by 3D ultrasound and D-Dimers rate
[Time Frame: Week 22]
|
|
Secondary ID(s)
|
|
0808025
|
|
2008-A00233-52
|
|
DGS2008-0193
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|