Clinical trial NCT01092949: Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
Official title: Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placental Insufficiency
Keywords: Placenta
perfusion
MRI
spin tagging
Gadolinium
placental insufficiency
urinary tract, sexual organs and pregnancy conditions
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing TOP at 16 to 32 weeks will be offered to participate in this study.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Establishment of physiological reference range of placental perfusion
timeFrame: 45 MIN
Secondary outcomes:
measure: 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
timeFrame: 45 MIN
measure: Comparison between the two measurements methods.
timeFrame: 45 MIN
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent Salomon, MCU PH
role: PRINCIPAL_INVESTIGATOR
References: