Obstetric Labor ComplicationsPelvi-MRINCT06485323
MRI Pseudo-CT Sequences for Obstetrical Pelvimetry.
A study testing MRI pelvimetry in people with Obstetric Labor Complications, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Obstetric Labor Complications
- What is being tested?
- MRI pelvimetry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jul 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
- Severe claustrophobia
- uncomfortable back position
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universaires Siant Luc
Brussels, 1200
Frederic Lecouvet, MD-PhD, +3227642793, frederic.lecouvet@saintluc.uclouvain.be
About this study
Official title: MRI Pseudo-CT Sequences for Obstetrical Pelvimetry
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.
Read the 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.
- Conditions
- Obstetric Labor Complications
- Being tested
- MRI pelvimetry
- Keywords
- technological progress
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI pelvimetryDevice
MRI of the pelvis
| Study group | Role | What they receive |
|---|---|---|
| IRM + CT scan for Pelvimetry | Experimental | Not described Receives: Device: MRI pelvimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prove the non-inferiority of MRI compared to CT for pelvimetry.
Measurement of pelvic bone diameters in pregnant women
Measured: 30 minutes (duration of the exam+ measurement)
Secondary outcomes (1)
Evaluate patient convenience for both examinations (CT and MRI)
questionnaire (scale from zero to ten, zero = more pleasant, ten=least pleasant)
Measured: immediately after both examinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start5 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each patients will have a CT scan (classic follow-up) and an MRI (for the study)
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Lecouvet, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485323
- Sponsor's protocol ID
- 2023/07AVR/174
- Acronym
- Pelvi-MRI
- Status last verified
- Apr 2026
- First submitted
- 27 May 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29464757Li 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.
PubMed 36675370Liao 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.
PubMed 29685537
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Pseudo-CT Sequences for Obstetrical Pelvimetry
- ClinicalTrials.gov ID
- NCT06485323
- Acronym / sponsor ID
- Pelvi-MRI / 2023/07AVR/174
- Conditions
- Obstetric Labor Complications
- Keywords
- technological progress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each patients will have a CT scan (classic follow-up) and an MRI (for the study)
| Arm | Type | Receives |
|---|---|---|
| IRM + CT scan for Pelvimetry | Experimental | Device: MRI pelvimetry |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Usual contraindications to MRI (Pacemaker, Metallic foreign body, Cochlear implant,…)
- Severe claustrophobia
- uncomfortable back position
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI pelvimetryMRI of the pelvis | Device | IRM + CT scan for Pelvimetry |
Primary outcome
Prove the non-inferiority of MRI compared to CT for pelvimetry.
Time frame: 30 minutes (duration of the exam+ measurement)
Measurement of pelvic bone diameters in pregnant women
1 secondary outcome
Evaluate patient convenience for both examinations (CT and MRI)
Time frame: immediately after both examinations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 29464757Hampel 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.
- Background: PubMed 36675370Li 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.
- Background: PubMed 29685537Liao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frédéric Lecouvet, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI pelvimetry in people with Obstetric Labor Complications, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric Lecouvet, MD, PhD (+3227642793, frederic.lecouvet@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prove the non-inferiority of MRI compared to CT for pelvimetry. (time frame: 30 minutes (duration of the exam+ measurement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485323, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.