Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01092949
Enrollment
135
Registered
2010-03-25
Start date
2010-02-01
Completion date
2018-09-01
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placental Insufficiency

Keywords

Placenta, perfusion, MRI, spin tagging, Gadolinium, placental insufficiency, urinary tract, sexual organs and pregnancy conditions

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.

Interventions

DEVICEMRI

MRI, 45 minutes

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Establishment of physiological reference range of placental perfusion45 MINEstablishment of physiological reference range of placental perfusion

Secondary

MeasureTime frame
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 placenta45 MIN
Comparison between the two measurements methods.45 MIN

Countries

France

Contacts

PRINCIPAL_INVESTIGATORLaurent Salomon, MCU PH

Assistance Publique Hopitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026