Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Establishment of physiological reference range of placental perfusion
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Establishment of physiological reference range of placental perfusion
Time Frame: 45 MIN
Establishment of physiological reference range of placental perfusion
Secondary Outcomes
- 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)