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

Completed

• Conditions: Placental Insufficiency

• Registration Number: NCT01092949
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Primary Completion: 2018-03
• Study Completion: 2018-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of physiological reference range of placental perfusion	45 MIN	Establishment of physiological reference range of placental perfusion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Necker Enfants Malades; 🇫🇷 Paris, France