Overview

This trial is active, not recruiting.

Condition placental insufficiency
Treatment mri
Sponsor Assistance Publique - Hôpitaux de Paris
Start date February 2010
End date March 2016
Trial size 135 participants
Trial identifier NCT01092949, 2009-A01024-63, P 081111

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Establishment of physiological reference range of placental perfusion
time frame: 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
time frame: 45 MIN
Comparison between the two measurements methods.
time frame: 45 MIN

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Reference Ranges for Placental Perfusion Using Magnetic Resonance Imaging (MRI)PLACENTIMAGE
Principal investigator Laurent Salomon, MCU PH
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.