Premature DeliveryNCT02859298
Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery.
A study testing Uterine Cervix Polarimetric Imaging in people with Premature Delivery, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of premature delivery (TPD), the most important complication and the leading cause of hospitalization during pregnancy has multiple origins which are seldom precisely identified. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Delivery
- What is being tested?
- Uterine Cervix Polarimetric Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Aug 2016to 24 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- normal pregnancy for control group
- threat of premature delivery after 24 weeks of pregnancy for test group
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery : The POLARMAP Project
Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of premature delivery (TPD), the most important complication and the leading cause of hospitalization during pregnancy has multiple origins which are seldom precisely identified.
The standard medical examination for the detection of patients with TPD is the endovaginal ultrasonographic examination of uterine cervix (echography).
Read more
Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging technologies with polarized light. The polarization is the spatio-temporal orientation of a wave's electric field. This light property, invisible with the naked eye, is sensitive to the morphological transformations of a tissue and the orientation of collagen fibers. Such tool would not require an extensive training and should provide an objective quantitative result with a sensitivity and specificity greater than conventional ultrasonography. This would be a considerable contribution to the health care of TPD, a real societal problem in Belgium, Europe and all over the world.
The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the structural evolution, the density and the orientation changes of collagen fibers. A relevant scoring of collagen status might provide an alternative, and potentially objective and accurate quantifier of the time left before delivery.
Read the detailed description
Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of premature delivery (TPD), the most important complication and the leading cause of hospitalization during pregnancy has multiple origins which are seldom precisely identified.
In Belgium and Europe, the estimated rate of premature births is about 10 %. This rate has been stable over the last two decades in spite of the introduction of new tocolytic treatments and the use of cervical length measurement by transvaginal ultrasound to assess the risk of preterm birth.
The standard medical examination for the detection of patients with TPD is the endovaginal ultrasonographic examination of uterine cervix (echography). Ultrasound examination is more accurate and reproducible compared to cervical digital one, and it possesses two essential qualities of a diagnostic examination: it is easily accepted by the patients and the learning curve is fast.
This technique is validated with well-known criteria, namely, the shortening of the effective length and the opening of the internal orifice of the cervix. The threshold for these two criteria depends on the practitioner's choice: at 30 mm effective length, the sensitivity and negative predictive values are high, but the specificity is poor, while the opposite is true if the threshold is set at 20 mm.
Ultrasound examination for the identification of the patients at risk of premature delivery is a real improvement over cervical digital examination. However, this technique is not ideal, due to the lack of objective criteria for the choice of threshold, because of the imperfect correlation ("noise") between the measured effective length of uterine cervix and the time left before the birth. Moreover, the use of cervical ultrasonography in the strategy of premature delivery screening is not well established.Finally, the transvaginal ultrasound probes are not available in all perinatal centers that would be yet all concerned in case of preterm delivery.
Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging technologies with polarized light. The polarization is the spatio-temporal orientation of a wave's electric field. This light property, invisible with the naked eye, is sensitive to the morphological transformations of a tissue and the orientation of collagen fibers. Such tool would not require an extensive training and should provide an objective quantitative result with a sensitivity and specificity greater than conventional ultrasonography. This would be a considerable contribution to the health care of TPD, a real societal problem in Belgium, Europe and all over the world.
The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the structural evolution, the density and the orientation changes of collagen fibers.
During the whole pregnancy and until its very end, the cervix is kept closed by abundant and well-organized collagen (the main structural protein in cervical tissue), when the collagen is partly destroyed and/or disorganized before the onset of labor. These changes in collagen structure, which soften the cervix and allow its opening for child birth, have been seen for both premature and full-term births. A relevant scoring of collagen status might thus provide an alternative, and potentially objective and accurate quantifier of the time left before delivery.
- Conditions
- Premature Delivery
- Being tested
- Uterine Cervix Polarimetric Imaging
- Keywords
- Premature Delivery, Polarimetric Imaging, Polarimetric colposcope, Diagnostic tool
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine Cervix Polarimetric ImagingDevice
Polarimetric imaging is a promising optical technique that can provide information in large field and potentially in vivo about the abundance and 3D structure of collagen. Images will be taken with a polarimetric colposcope. As the imaging is realized with visible light from classical sources (lamps or LEDs, neither lasers or other high intensity sources, nor any ionizing UV radiation) and without any chemicals, it is totally innocuous, just like the intensity imaging used in conventional colposcopy.
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of threat of premature delivery | Experimental | 10 consecutive patients arriving at the Brugmann maternity with suspicion of a threat of premature delivery will be encouraged to participate in this study, before the onset of any tocolytic treatment. The patient will receive an standard examination of the cervix and at the same time a polarimetric measurement. Receives: Device: Uterine Cervix Polarimetric Imaging |
| Normal pregnancy | Active comparator | 10 control patients, with the same term of pregnancy, will be benefit from the same measurements. Receives: Device: Uterine Cervix Polarimetric Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal to noise ratio
Measure of polarimetric imaging feasibility. Signal to noise ratio in a measurement time compatible with in vivo imaging (less than one second)
Measured: 1 second
Reproducibility (%)
Reproducibility of acquired images (expressed in %)
Measured: 1 second
Lickert scale
Measure of the acceptability of the patient (psychometric scale to be filled by the patient)
Measured: 10 minutes
Secondary outcomes (2)
Retardance
Correlation between retardance (polarimetric parameter) and premature delivery.
Measured: 1 second
Depolarization
Correlation between depolarization (polarimetric parameter) and premature delivery.
Measured: 1 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start9 Aug 2016
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Why it stopped: Lack of human ressources
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 Premature DeliveryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Nazac, Brugmann University Hospital
- Investigators
- André Nazac, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859298
- Sponsor's protocol ID
- CHUB-Polarmap
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2016
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pierangelo A, Nazac A, Benali A, Validire P, Cohen H, Novikova T, Ibrahim BH, Manhas S, Fallet C, Antonelli MR, Martino AD. Polarimetric imaging of uterine cervix: a case study. Opt Express. 2013 Jun 17;21(12):14120-30. doi: 10.1364/OE.21.014120.
PubMed 23787602Rehbinder J, Haddad H, Deby S, Teig B, Nazac A, Novikova T, Pierangelo A, Moreau F. Ex vivo Mueller polarimetric imaging of the uterine cervix: a first statistical evaluation. J Biomed Opt. 2016 Jul 1;21(7):71113. doi: 10.1117/1.JBO.21.7.071113.
PubMed 27108592Bancelin S, Nazac A, Ibrahim BH, Dokladal P, Decenciere E, Teig B, Haddad H, Fernandez H, Schanne-Klein MC, De Martino A. Determination of collagen fiber orientation in histological slides using Mueller microscopy and validation by second harmonic generation imaging. Opt Express. 2014 Sep 22;22(19):22561-74. doi: 10.1364/OE.22.022561.
PubMed 25321725
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery : The POLARMAP Project
- ClinicalTrials.gov ID
- NCT02859298
- Acronym / sponsor ID
- CHUB-Polarmap
- Conditions
- Premature Delivery
- Keywords
- Premature Delivery, Polarimetric Imaging, Polarimetric colposcope, Diagnostic tool
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of human ressources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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.
Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of premature delivery (TPD), the most important complication and the leading cause of hospitalization during pregnancy has multiple origins which are seldom precisely identified.
The standard medical examination for the detection of patients with TPD is the endovaginal ultrasonographic examination of uterine cervix (echography).
Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging technologies with polarized light. The polarization is the spatio-temporal orientation of a wave's electric field. This light property, invisible with the naked eye, is sensitive to the morphological transformations of a tissue and the orientation of collagen fibers. Such tool would not require an extensive training and should provide an objective quantitative result with a sensitivity and specificity greater than conventional ultrasonography. This would be a considerable contribution to the health care of TPD, a real societal problem in Belgium, Europe and all over the world.
The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the structural evolution, the density and the orientation changes of collagen fibers. A relevant scoring of collagen status might provide an alternative, and potentially objective and accurate quantifier of the time left before delivery.
Detailed description
Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of premature delivery (TPD), the most important complication and the leading cause of hospitalization during pregnancy has multiple origins which are seldom precisely identified.
In Belgium and Europe, the estimated rate of premature births is about 10 %. This rate has been stable over the last two decades in spite of the introduction of new tocolytic treatments and the use of cervical length measurement by transvaginal ultrasound to assess the risk of preterm birth.
The standard medical examination for the detection of patients with TPD is the endovaginal ultrasonographic examination of uterine cervix (echography). Ultrasound examination is more accurate and reproducible compared to cervical digital one, and it possesses two essential qualities of a diagnostic examination: it is easily accepted by the patients and the learning curve is fast.
This technique is validated with well-known criteria, namely, the shortening of the effective length and the opening of the internal orifice of the cervix. The threshold for these two criteria depends on the practitioner's choice: at 30 mm effective length, the sensitivity and negative predictive values are high, but the specificity is poor, while the opposite is true if the threshold is set at 20 mm.
Ultrasound examination for the identification of the patients at risk of premature delivery is a real improvement over cervical digital examination. However, this technique is not ideal, due to the lack of objective criteria for the choice of threshold, because of the imperfect correlation ("noise") between the measured effective length of uterine cervix and the time left before the birth. Moreover, the use of cervical ultrasonography in the strategy of premature delivery screening is not well established.Finally, the transvaginal ultrasound probes are not available in all perinatal centers that would be yet all concerned in case of preterm delivery.
Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging technologies with polarized light. The polarization is the spatio-temporal orientation of a wave's electric field. This light property, invisible with the naked eye, is sensitive to the morphological transformations of a tissue and the orientation of collagen fibers. Such tool would not require an extensive training and should provide an objective quantitative result with a sensitivity and specificity greater than conventional ultrasonography. This would be a considerable contribution to the health care of TPD, a real societal problem in Belgium, Europe and all over the world.
The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the structural evolution, the density and the orientation changes of collagen fibers.
During the whole pregnancy and until its very end, the cervix is kept closed by abundant and well-organized collagen (the main structural protein in cervical tissue), when the collagen is partly destroyed and/or disorganized before the onset of labor. These changes in collagen structure, which soften the cervix and allow its opening for child birth, have been seen for both premature and full-term births. A relevant scoring of collagen status might thus provide an alternative, and potentially objective and accurate quantifier of the time left before delivery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspicion of threat of premature delivery | Experimental | Device: Uterine Cervix Polarimetric Imaging10 consecutive patients arriving at the Brugmann maternity with suspicion of a threat of premature delivery will be encouraged to participate in this study, before the onset of any tocolytic treatment. The patient will receive an standard examination of the cervix and at the same time a polarimetric measurement. |
| Normal pregnancy | Active comparator | Device: Uterine Cervix Polarimetric Imaging10 control patients, with the same term of pregnancy, will be benefit from the same measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- normal pregnancy for control group
- threat of premature delivery after 24 weeks of pregnancy for test group
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Uterine Cervix Polarimetric ImagingPolarimetric imaging is a promising optical technique that can provide information in large field and potentially in vivo about the abundance and 3D structure of collagen. Images will be taken with a polarimetric colposcope. As the imaging is realized with visible light from classical sources (lamps or LEDs, neither lasers or other high intensity sources, nor any ionizing UV radiation) and without any chemicals, it is totally innocuous, just like the intensity imaging used in conventional colposcopy. | Device | Normal pregnancy, Suspicion of threat of premature delivery |
Primary outcome
Signal to noise ratio
Time frame: 1 second
Measure of polarimetric imaging feasibility. Signal to noise ratio in a measurement time compatible with in vivo imaging (less than one second)
Reproducibility (%)
Time frame: 1 second
Reproducibility of acquired images (expressed in %)
Lickert scale
Time frame: 10 minutes
Measure of the acceptability of the patient (psychometric scale to be filled by the patient)
2 secondary outcomes
Retardance
Time frame: 1 second
Depolarization
Time frame: 1 second
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Background: PubMed 23787602Pierangelo A, Nazac A, Benali A, Validire P, Cohen H, Novikova T, Ibrahim BH, Manhas S, Fallet C, Antonelli MR, Martino AD. Polarimetric imaging of uterine cervix: a case study. Opt Express. 2013 Jun 17;21(12):14120-30. doi: 10.1364/OE.21.014120.
- Background: PubMed 27108592Rehbinder J, Haddad H, Deby S, Teig B, Nazac A, Novikova T, Pierangelo A, Moreau F. Ex vivo Mueller polarimetric imaging of the uterine cervix: a first statistical evaluation. J Biomed Opt. 2016 Jul 1;21(7):71113. doi: 10.1117/1.JBO.21.7.071113.
- Background: PubMed 25321725Bancelin S, Nazac A, Ibrahim BH, Dokladal P, Decenciere E, Teig B, Haddad H, Fernandez H, Schanne-Klein MC, De Martino A. Determination of collagen fiber orientation in histological slides using Mueller microscopy and validation by second harmonic generation imaging. Opt Express. 2014 Sep 22;22(19):22561-74. doi: 10.1364/OE.22.022561.
Related trials for Premature Delivery
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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. This study is not recruiting at the moment.
André Nazac, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Cervix Polarimetric Imaging in people with Premature Delivery, run by Brugmann University Hospital 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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 7 Aug 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal to noise ratio (time frame: 1 second). The study lists 3 primary outcomes in all. 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 NCT02859298, 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 7 Aug 2020.