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

Placental Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092949
• Other study ID #: P 081111
• Secondary ID: 2009-A01024-63
• Status: Completed
• Start date: February 2010
• Est. completion date: September 2018

Study information

• Verified date: July 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Placental Insufficiency

Intervention

Device:
• MRI
MRI, 45 minutes

Locations

Country	Name	City	State
France	Necker Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of physiological reference range of placental perfusion	Establishment of physiological reference range of placental perfusion	45 MIN
Secondary	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
Secondary	Comparison between the two measurements methods.		45 MIN