MRI Pseudo-CT Sequences for Obstetrical Pelvimetry.

NCT06485323 | Recruiting

• 1 other identifier: 2023/07AVR/174
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Labor Complications

Keywords

technological progress

Outcome Measures

Primary Outcomes (1)

• Prove the non-inferiority of MRI compared to CT for pelvimetry.

  Measurement of pelvic bone diameters in pregnant women

  30 minutes (duration of the exam+ measurement)

Secondary Outcomes (1)

• Evaluate patient convenience for both examinations (CT and MRI)

  immediately after both examinations

Study Arms (1)

IRM + CT scan for Pelvimetry

EXPERIMENTAL

Device: MRI pelvimetry

Interventions

MRI pelvimetry DEVICE

MRI of the pelvis

IRM + CT scan for Pelvimetry

Eligibility Criteria

• Age: 18 Years - 99 Years
• Gender Eligibility Details: having an uterus
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
• Severe claustrophobia
• uncomfortable back position

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universaires Siant Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (3)

• 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.

  PMID: 29464757 BACKGROUND

• 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.

  PMID: 36675370 BACKGROUND

• 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.

  PMID: 29685537 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Frédéric Lecouvet, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Lecouvet, MD, PhD

CONTACT

+3227642793; frederic.lecouvet@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patients will have a CT scan (classic follow-up) and an MRI (for the study)

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: July 3, 2024
• Study Start: July 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)