Clinical trial NCT06485323: MRI Pseudo-CT Sequences for Obstetrical Pelvimetry.
Official title: MRI Pseudo-CT Sequences for Obstetrical Pelvimetry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstetric Labor Complications
Keywords: technological progress
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each patients will have a CT scan (classic follow-up) and an MRI (for the study)
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prove the non-inferiority of MRI compared to CT for pelvimetry.
timeFrame: 30 minutes (duration of the exam+ measurement)
Secondary outcomes:
measure: Evaluate patient convenience for both examinations (CT and MRI)
timeFrame: immediately after both examinations
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universaires Siant Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Frédéric Lecouvet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.