Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01092949
First received: February 26, 2010
Last updated: October 12, 2012
Last verified: February 2011

February 26, 2010
October 12, 2012
February 2010
February 2013   (final data collection date for primary outcome measure)
Establishment of physiological reference range of placental perfusion [ Time Frame: 45 MIN ] [ Designated as safety issue: No ]
Establishment of physiological reference range of placental perfusion
Establisment of physiological reference range of placental perfusion [ Time Frame: 45 MIN ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01092949 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: 45 MIN ] [ Designated as safety issue: No ]
  • Comparison between the two measurements methods. [ Time Frame: 45 MIN ] [ Designated as safety issue: No ]
  • To quantify in vivo and by a not invasive way the microscopic physiological phenomena relative to the placental perfusion and in the local transcapillare exchanges of the placenta [ Time Frame: 45 MIN ] [ Designated as safety issue: No ]
  • Comparison between the two measurements methods. [ Time Frame: 45 MIN ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE

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.

Objective:

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.

Method:

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

120 patients will be included. 15 per group of weeks of gestation: 16+0-17+6 SA, 18+0-19+6 SA, 20+0-21+6 SA, 22+0-23+6 SA, 24+0-25+6 SA, 26+0-27+6 SA, 28+0-29+6 SA, 30+0-31+6 WG.

MRI will be performed in the same hospital, during hospital stay, within 45 minutes.

Two MRI sequences will be used to measure placental perfusion:

  • dynamic sequences using Gd contrast agent.
  • " spin tagging ", which do not need any contrast agent. Perfusion will be modelled using compartmental analysis. Reference ranges will be build up by statistical modelling. Gadolinium assays will be performed on amniotic fluid and placental tissue following TOP.

Duration of inclusion: 24 months.

Duration of patient participation: 45 minutes.

Expected results:

  • Feasibility in routine practice.
  • Reference ranges for placental perfusion.
  • Comparison between the two measurements methods.

Adverse outcome measure:

Nausea, vomiting, lack of comfort and other adverse outcome.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Placental Insufficiency
Device: MRI
MRI, 45 minutes
Other Name: MRI, 45 minutes
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Placental adhesion anomaly,
  • Chromosomal abnormality,
  • Growth restriction,
  • Contrast agent allergy,
  • Absent consent,
  • Contraindication of MRI or Gadolinium,
  • Renal insufficiency,
  • Asthmatic antecedent,
  • Placental abnormality at pathological examination.
Female
18 Years and older
No
Contact: Laurent Salomon, MCU PH +33(0)1 44 49 40 30 ext +33 laurentsalomon@gmail.com
France
 
NCT01092949
P 081111, 2009-A01024-63
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Laurent Salomon, MCU PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP