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Placenta Vascular MalformationVOLUPLANCT00767182

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

An observational study of Placenta Vascular Malformation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Placenta Vascular Malformation
What is being tested?
blood sample
How many people
40 participants
Where
1 siteFrance
Study dates
Aug 2008to Aug 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: community sample

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de Gynécologie Obstétrique - CHU Saint-Etienne

    Saint-Etienne, 42055

Other trials in France

About this study

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

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.

Read the 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.

Being tested
blood sample
Keywords
preeclampsia, eclampsia, retroplacental hematoma, vascular IUGR, IUFD, placental volume
Medical subject headings
Pre-Eclampsia, Eclampsia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood sampleOther

    biological markers evaluated : D-Dimer, sEPCR

Study groups in NCT00767182
Study groupRoleWhat they receive
Pregnant patients with VPP antecedentPregnancy 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.
Receives: Other: blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Week 12

Secondary outcomes (8)

  1. EPCRs rate measurements

    Measured: Week 12

  2. EPCRs rate measurements

    Measured: Week 16

  3. EPCRs rate measurements

    Measured: Week 22

  4. Occurrence or recurrence of PVP

    Measured: Week 12

  5. Occurrence or recurrence of PVP

    Measured: Week 16

  6. Occurrence or recurrence of PVP

    Measured: Week 22

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

    Measured: Week 16

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

    Measured: Week 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00767182
Sponsor's protocol ID
0808025
Other IDs
2008-A00233-52, DGS2008-0193
Acronym
VOLUPLA
Status last verified
Mar 2016
First submitted
3 Oct 2008
Last updated
23 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Placenta Vascular Malformation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

placental volume by 3D ultrasound and D-Dimers rate (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00767182.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.

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