MRI Pseudo-CT Sequences for Obstetrical Pelvimetry.

NCT ID: NCT06485323

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-05

Study Completion Date

2025-12-31

Brief Summary

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It is possible to perform a pelvimetry by MRI as a substitute to pelvimetry by CT, hence sparing the patient from a dose of irradiation.

Detailed Description

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The Principal investigator want to evaluate new MRI sequences offering both an optimal contrast between mineral bone and soft tissues, and a shorter acquisition time. Indeed, the recent developments of specific MRI sequences to preferentially image the mineral bone (namely the ZTE and lavaflex 3D T1-weighted SPGR sequences) allow performing pelvimetry measurements on MR images offering an optimal "pseudo CT" contrast, with an MR acquisition time that is less than 10 minutes. Preliminary tests of these sequences have been carried out in our center in order to be able to implement these sequences on our clinical and research MRI machines. The study team wish to undertake a study to validate the use of this rapid and non-irradiating MRI approach, with the aim to replace a CT pelvimetry by a MRI pelvimetry demonstrated as being as reliable.

Conditions

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Obstetric Labor Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Each patients will have a CT scan (classic follow-up) and an MRI (for the study)
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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IRM + CT scan for Pelvimetry

Group Type EXPERIMENTAL

MRI pelvimetry

Intervention Type DEVICE

MRI of the pelvis

Interventions

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MRI pelvimetry

MRI of the pelvis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pregnant woman 33 to 41 week
* Woman who gave birth by cesarean section, for whom the obstetrician requests a pelvimetry CT for the next pregnancy
* Pelvimetry planned by the obstetrical team outside of "emergency" pathway
* Adhere to the study protocol after reading the patient information document have signed the informed consent form to participate in the study

Exclusion Criteria

* Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
* Severe claustrophobia
* uncomfortable back position
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric Lecouvet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universaires Siant Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Frédéric Lecouvet, MD, PhD

Role: CONTACT

+3227642793

Facility Contacts

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Frederic Lecouvet, MD-PhD

Role: primary

+3227642793

References

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Hampel F, Hallscheidt P, Sohn C, Schlehe B, Brocker KA. Pelvimetry in nulliparous and primiparous women using 3 Tesla magnetic resonance imaging. Neurourol Urodyn. 2018 Aug;37(6):1950-1956. doi: 10.1002/nau.23537. Epub 2018 Feb 21.

Reference Type BACKGROUND
PMID: 29464757 (View on PubMed)

Li J, Lou Y, Chen C, Zheng W, Chen Y, Dong T, Yang M, Zhao B, Luo Q. Predictive Value of MRI Pelvimetry in Vaginal Delivery and Its Practicability in Prolonged Labour-A Prospective Cohort Study. J Clin Med. 2023 Jan 5;12(2):442. doi: 10.3390/jcm12020442.

Reference Type BACKGROUND
PMID: 36675370 (View on PubMed)

Liao KD, Yu YH, Li YG, Chen L, Peng C, Liu P, Chen CL, Chen RY, Zhong M, Wang Y. Three-dimensional magnetic resonance pelvimetry: A new technique for evaluating the female pelvis in pregnancy. Eur J Radiol. 2018 May;102:208-212. doi: 10.1016/j.ejrad.2018.03.024. Epub 2018 Mar 19.

Reference Type BACKGROUND
PMID: 29685537 (View on PubMed)

Other Identifiers

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2023/07AVR/174

Identifier Type: -

Identifier Source: org_study_id

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