NCT01092949

Brief Summary

To evaluate the feasibility of functional MRI method developed in an animal model and to construct normal reference ranges for in vivo placental perfusion using functional MRI. This will be based on imaging studies in patients undergoing termination of pregnancy (TOP) at 16 to 32 weeks' for fetal reason in a tertiary referral center.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2010

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

8.1 years

First QC Date

February 26, 2010

Last Update Submit

March 6, 2026

Conditions

Keywords

PlacentaperfusionMRIspin taggingGadoliniumplacental insufficiencyurinary tract, sexual organs and pregnancy conditions

Outcome Measures

Primary Outcomes (1)

  • Establishment of physiological reference range of placental perfusion

    Establishment of physiological reference range of placental perfusion

    45 MIN

Secondary Outcomes (2)

  • To quantify in vivo and by a not invasive way the microscopic physiological phenomena relative to the placental perfusion and in the local transcapillary exchanges of the placenta

    45 MIN

  • Comparison between the two measurements methods.

    45 MIN

Interventions

MRIDEVICE

MRI, 45 minutes

Also known as: MRI, 45 minutes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.

You may qualify if:

  • Women \> 18 years,
  • Undergoing TOP for fetal reason,
  • Informed signed consent.

You may not qualify if:

  • Placental adhesion anomaly,
  • Growth restriction,
  • Contrast agent allergy,
  • Absent consent,
  • Contraindication of MRI or Gadolinium,
  • Renal insufficiency,
  • Placental abnormality at pathological examination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (2)

  • Deloison B, Arthuis C, Benchimol G, Balvay D, Bussieres L, Millischer AE, Grevent D, Butor C, Chalouhi G, Mahallati H, Helenon O, Tavitian B, Clement O, Ville Y, Siauve N, Salomon LJ. Human placental perfusion measured using dynamic contrast enhancement MRI. PLoS One. 2021 Sep 2;16(9):e0256769. doi: 10.1371/journal.pone.0256769. eCollection 2021.

  • Siauve N, Hayot PH, Deloison B, Chalouhi GE, Alison M, Balvay D, Bussieres L, Clement O, Salomon LJ. Assessment of human placental perfusion by intravoxel incoherent motion MR imaging. J Matern Fetal Neonatal Med. 2019 Jan;32(2):293-300. doi: 10.1080/14767058.2017.1378334. Epub 2017 Oct 3.

MeSH Terms

Conditions

Placental Insufficiency

Condition Hierarchy (Ancestors)

Placenta DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Laurent Salomon, MCU PH

    Assistance Publique Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 25, 2010

Study Start

February 1, 2010

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations