Pregnancy RelatedCOLPOTERMENCT04661553
Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
A study testing Mueller's polarimetric colposcopy "Group 1" and Mueller's polarimetric colposcopy "Group 2" in people with Pregnancy Related and Premature Birth, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Mueller polarimetric colposcopy appears to be a powerful tool for evaluating cervical microstructure modification during pregnancy. Some polarimetric parameters of the uterine cervix can be correlated with the gestational age. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Premature Birth
- What is being tested?
- Mueller's polarimetric colposcopy "Group 1" and Mueller's polarimetric colposcopy "Group 2"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 683 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2020to 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient.
- Single pregnancy.
- Baseline ≥ 20 amenorrhea week for group 1 and baseline ≥ 20 amenorrhea week and <37 amenorrhea week for group 2.
- Dating obtained by ultrasound of the 1st trimester.
- Written and informed consent.
- Group 1 (low risk):
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- Asymptomatic patient benefiting from usual follow-up in the maternity hospital.
- > Group 2 (high risk): Symptomatic patient with cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of <20mm.
- Asymptomatic patient with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of <20mm."
Who cannot join
- Known uterine malformation or suspected uterine malformation.
- Pregnancy circled.
- Premature rupture of membranes.
- Suspicion of chorioamnionitis.
- Abundant active bleeding hindering the visualization of the cervix.
- History of conization.
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- Imminent childbirth.
- Known medical indication at a birth <37 amenorrhea week (severe pre-eclampsia, severe intrauterine growth retardation, hemorrhagic placenta previa, fetal malformations,….).
- Examination of the cervix under speculum not possible.
- Lack of social coverage (AME).
- Limited understanding.
- Participation in another intervention research.
- > Group1 (Low risk):
- History of spontaneous premature labor.
- History of late miscarriage.
- History of premature rupture of membranes."
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospital Bicêtre - Gynecology-Obstetrics Department
Le Kremlin-Bicêtre, France, 94275
Dominique LUTON, Pr, 01 45 21 77 64, dominique.luton@aphp.fr
Dominique LUTON, Pr
About this study
Official title: Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy (COLPOTERME)
Mueller polarimetric colposcopy appears to be a powerful tool for evaluating cervical microstructure modification during pregnancy. Some polarimetric parameters of the uterine cervix can be correlated with the gestational age. The uterine cervix's polarimetric analysis could make it possible to accurately predict the term of childbirth and be used as a screening tool for preterm birth.
Read the detailed description
Interventional research protocol involving the human person relating to a medical device. This is a prospective, not randomized, monocentric study. Prematurity accounts for around 11% of births worldwide. In France, around 60,000 children (7.4%) are born each year prematurely. The term of gestation has a strong impact on mortality, severe neonatal morbidity, and child development. For this reason, premature birth represents a major public health issue. The means to reliably predict a premature birth are still ineffective. The medical device used in this research is a Mueller polarimetric colposcope which appears to be a powerful tool for evaluating the process of remodeling of cervical microstructure during pregnancy.
Mueller polarimetric imaging is the only technique that enables obtaining the comprehensive polarimetric characterization of a sample. Two groups are considered for this study: i) patients at low risk of premature birth (Group 1); ii) patients at high risk of premature birth (Group 2).
This study's main objective is to determine, for the two groups of patients, the best "polarimetric biomarkers" which make it possible to define an optimal "polarimetric score" reflecting the state of the cervical microstructure throughout its remodeling process during pregnancy.
This "Polarimetric Score" will be able to predict the term of childbirth and used as a screening tool for prematurity.
- Conditions
- Pregnancy Related, Premature Birth
- Being tested
- Mueller's polarimetric colposcopy "Group 1", Mueller's polarimetric colposcopy "Group 2"
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mueller's polarimetric colposcopy "Group 1"Device
Determination of the best "polarimetric biomarkers" reflecting the status of the cervical microstructure throughout its remodeling process due to the pregnancy in a population with a low-risk premature birth. This "polarimetric biomarkers" should make it possible to accurately determine the time remaining before childbirth for a normal pregnancy and, therefore, to monitor the regular advancement of the gestation.
Mueller's polarimetric colposcopy "Group 2"Device
Determination of the best "polarimetric biomarkers" reflecting the status of the cervical microstructure throughout its remodeling process due to the pregnancy in a population at high-risk of preterm birth.
This "polarimetric biomarkers" should make it possible to accurately determine the time remaining before childbirth for an abnormal pregnancy and, therefore, to predict premature childbirth.
| Study group | Role | What they receive |
|---|---|---|
| Group1: patients with a low risk of premature birth | Experimental | Asymptomatic patient receiving usual follow-up in the maternity ward. Receives: Device: Mueller's polarimetric colposcopy "Group 1" |
| Group2: patients with a high risk of premature birth | Experimental | Symptomatic patients with cervical changes objectified by endovaginal ultrasound of the cervix with length <20mm. Asymptomatic patients with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with length <20mm. Receives: Device: Mueller's polarimetric colposcopy "Group 2" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polarimetric parameters in population with a low-risk of premature birth
The principal outcome will be determining the best "polarimetric biomarkers" able to monitor and quantify the uterine cervix's modifications in a population with a low risk of premature birth. Specifically, the "polarimetric biomarkers" are the most relevant polarimetric parameters (or a combination of them) characterizing the cervical microstructure modifications during a normal pregnancy. They can be the main polarimetric parameters obtained from the measured Mueller matrices using different algebraic methods.
One example of a polarimetric parameter that can be assessed is the Phase Retardance, measured in degrees at different wavelengths. It characterizes the anisotropy of the tissue.
Measured: 6 months
Polarimetric biomarkers in population with a low-risk of premature birth
A polarimetric parameter that can be assessed is the azimuth of the Phase Retardance, measured in degrees at different wavelengths. It characterizes the orientations of the microscopic fibrous structures (such as the collagen) in the tissue.
Measured: 6 months
Parameters Polarimetric in population with a low-risk of premature birth
A polarimetric parameter that can be assessed is the Depolarization, measured in arbitrary units at different wavelengths. It characterizes the scattering properties of the tissue.
Measured: 6 months
Secondary outcomes (3)
Polarimetric parameters in population with a high-risk of premature birth
A polarimetric parameter that can be assessed is the azimuth of the Phase Retardance, measured in degrees at different wavelengths. It characterizes the orientations of the microscopic fibrous structures (such as the collagen) in the tissue.
Measured: 6 months
Polarimetric biomarkers in population with a high-risk of premature birth
A polarimetric parameter that can be assessed is the Depolarization, measured in arbitrary units at different wavelengths. It characterizes the scattering properties of the tissue.
Measured: 6 months
Parameters polarimetric in population with a high-risk of premature birth
The principal outcome will be determining the best "polarimetric biomarkers" able to monitor and quantify the uterine cervix's modifications in a population with a high risk of premature birth. Specifically, the "polarimetric biomarkers" are the most relevant polarimetric parameters (or a combination of them) characterizing the cervical microstructure modifications during a normal pregnancy. They can be the main polarimetric parameters obtained from the measured Mueller matrices using different algebraic methods.
One example of a polarimetric parameter that can be assessed is the Phase Retardance, measured in degrees at different wavelengths. It characterizes the anisotropy of the tissue.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start22 Dec 2020
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 683 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique LUTON, Pr, Principal investigator, Obstetrics gynecology department - Bicetre hospital, Kremlin Bicetre, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661553
- Sponsor's protocol ID
- APHP191010
- Other IDs
- 2020-A01932-37
- Acronym
- COLPOTERME
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy (COLPOTERME)
- ClinicalTrials.gov ID
- NCT04661553
- Acronym / sponsor ID
- COLPOTERME / APHP191010
- Conditions
- Pregnancy Related, Premature Birth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 683 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Dec 2020 (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.
Mueller polarimetric colposcopy appears to be a powerful tool for evaluating cervical microstructure modification during pregnancy. Some polarimetric parameters of the uterine cervix can be correlated with the gestational age. The uterine cervix's polarimetric analysis could make it possible to accurately predict the term of childbirth and be used as a screening tool for preterm birth.
Detailed description
Interventional research protocol involving the human person relating to a medical device. This is a prospective, not randomized, monocentric study. Prematurity accounts for around 11% of births worldwide. In France, around 60,000 children (7.4%) are born each year prematurely. The term of gestation has a strong impact on mortality, severe neonatal morbidity, and child development. For this reason, premature birth represents a major public health issue. The means to reliably predict a premature birth are still ineffective. The medical device used in this research is a Mueller polarimetric colposcope which appears to be a powerful tool for evaluating the process of remodeling of cervical microstructure during pregnancy.
Mueller polarimetric imaging is the only technique that enables obtaining the comprehensive polarimetric characterization of a sample. Two groups are considered for this study: i) patients at low risk of premature birth (Group 1); ii) patients at high risk of premature birth (Group 2).
This study's main objective is to determine, for the two groups of patients, the best "polarimetric biomarkers" which make it possible to define an optimal "polarimetric score" reflecting the state of the cervical microstructure throughout its remodeling process during pregnancy.
This "Polarimetric Score" will be able to predict the term of childbirth and used as a screening tool for prematurity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: patients with a low risk of premature birth | Experimental | Device: Mueller's polarimetric colposcopy "Group 1"Asymptomatic patient receiving usual follow-up in the maternity ward. |
| Group2: patients with a high risk of premature birth | Experimental | Device: Mueller's polarimetric colposcopy "Group 2"Symptomatic patients with cervical changes objectified by endovaginal ultrasound of the cervix with length <20mm. Asymptomatic patients with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with length <20mm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Major patient.
- Single pregnancy.
- Baseline ≥ 20 amenorrhea week for group 1 and baseline ≥ 20 amenorrhea week and <37 amenorrhea week for group 2.
- Dating obtained by ultrasound of the 1st trimester.
- Written and informed consent.
Key exclusion criteria (16 listed)
- Known uterine malformation or suspected uterine malformation.
- Pregnancy circled.
- Premature rupture of membranes.
- Suspicion of chorioamnionitis.
- Abundant active bleeding hindering the visualization of the cervix.
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 |
|---|---|---|
| Mueller's polarimetric colposcopy "Group 1"Determination of the best "polarimetric biomarkers" reflecting the status of the cervical microstructure throughout its remodeling process due to the pregnancy in a population with a low-risk premature birth. This "polarimetric biomarkers" should make it possible to accurately determine the time remaining before childbirth for a normal pregnancy and, therefore, to monitor the regular advancement of the gestation. | Device | Group1: patients with a low risk of premature birth |
| Mueller's polarimetric colposcopy "Group 2"Determination of the best "polarimetric biomarkers" reflecting the status of the cervical microstructure throughout its remodeling process due to the pregnancy in a population at high-risk of preterm birth. This "polarimetric biomarkers" should make it possible to accurately determine the time remaining before childbirth for an abnormal pregnancy and, therefore, to predict premature childbirth. | Device | Group2: patients with a high risk of premature birth |
Primary outcome
Polarimetric parameters in population with a low-risk of premature birth
Time frame: 6 months
The principal outcome will be determining the best "polarimetric biomarkers" able to monitor and quantify the uterine cervix's modifications in a population with a low risk of premature birth. Specifically, the "polarimetric biomarkers" are the most relevant polarimetric parameters (or a combination of them) characterizing the cervical microstructure modifications during a normal pregnancy. They can be the main polarimetric parameters obtained from the measured Mueller matrices using different algebraic methods. One example of a polarimetric parameter that can be assessed is the Phase Retardance, measured in degrees at different wavelengths. It characterizes the anisotropy of the tissue.
Polarimetric biomarkers in population with a low-risk of premature birth
Time frame: 6 months
A polarimetric parameter that can be assessed is the azimuth of the Phase Retardance, measured in degrees at different wavelengths. It characterizes the orientations of the microscopic fibrous structures (such as the collagen) in the tissue.
Parameters Polarimetric in population with a low-risk of premature birth
Time frame: 6 months
A polarimetric parameter that can be assessed is the Depolarization, measured in arbitrary units at different wavelengths. It characterizes the scattering properties of the tissue.
3 secondary outcomes
Polarimetric parameters in population with a high-risk of premature birth
Time frame: 6 months
Polarimetric biomarkers in population with a high-risk of premature birth
Time frame: 6 months
Parameters polarimetric in population with a high-risk of premature birth
Time frame: 6 months
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 21 Jan 2026.
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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.
Dominique LUTON, Pr principal investigator
Obstetrics gynecology department - Bicetre hospital, Kremlin Bicetre, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mueller's polarimetric colposcopy "Group 1" and Mueller's polarimetric colposcopy "Group 2" in people with Pregnancy Related and Premature Birth, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 9 inclusion and 16 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 21 Jan 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 France. 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 Dominique LUTON, Pr (01 45 21 77 64, dominique.luton@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polarimetric parameters in population with a low-risk of premature birth (time frame: 6 months). 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?
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 21 Jan 2026.