Preterm LabourPHENOMAPNCT01340222
Monocyte Chemotactic Protein-1 (MCP-1) Expressing Monocytes to Predict Preterm Delivery: PhenoMAP Study
A study testing biological samples in people with Preterm Labour, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The threat of preterm labour (PTL) is the first cause of hospitalization in the course of pregnancy. Its diagnostic is based on clinical examination with a positive predictive value of about 40 %. 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
- Preterm Labour
- What is being tested?
- biological samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Jul 2015
- 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
- Threat of preterm labour (PTL) occurring between 24 and 34 WOA, defined according to validated criteria i.e. by (1) the presence of regular uterine contractions, lasting at least 30 seconds at a frequency ≥ 4 contractions every 30 minutes and confirmed by an external tocogram, (2) a cervical dilation of 3 cm or greater, to focus on true preterm labour, for the nulliparous women and 1-3 cm among primiparous women or multiparous and (3) a cervical obliteration >50%, or a cervix less than 25mm according to the echography, when this information is available. The first two criteria being mandatory, the third one optional as it is more subjective, or less likely to be available for every patient.
- Person who has given written consent
- Singleton pregnancy
- Person who has given written consent
- Group 1: Women of reproductive age who have never had a pregnancy, even if not completed to term.
- Group 2: Single full-term, uncomplicated pregnancy (= out of hospital) older than 6 months.
Who cannot join
- Pre-existing diabetes or gestational diabetes, morbid obesity (BMI > 35 kg/m2) as these situations modify the expression of MCP-1.
- Woman presenting a spontaneous rupture of membranes (SRM) with confirmed or probable chorioamniotitis
- Inflammatory or auto-immune disease
- Suspected or confirmed infectious disease, including HIV, HCV, HBV
- Anti-inflammatory drug treatment or immuno-modulator.
- Multiple pregnancies
Show all 17Show fewer
- PTL <24 WOA or >34 WOA
- Patient less than 18 years of age.
- Patient not affiliated to social security insurance
- Pre-existing diabètes
- Morbid obesity (BMI > 35 kg/m2)
- Inflammatory or auto-immune disease
- Suspected or confirmed infectious disease, including HIV, HCV, HBV
- Anti-inflammatory drug treatment or immuno-modulator.
- Minor person
- Person not affiliated to social security insurance
- History of twin pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Prognostic Value of Monocytes and Lymphocyte Phenotyping, Along With Intracellular MCP-1 Expression, to Predict Preterm Delivery for Women Hospitalized for Threat of Preterm Labor Between 24 and 34 Weeks of Amenorrhea: PhenoMAP Study
The threat of preterm labour (PTL) is the first cause of hospitalization in the course of pregnancy. Its diagnostic is based on clinical examination with a positive predictive value of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been suggested by its secretion in the amniotic fluid during labour and by the increase in the expression of its RNA messengers in the peripheral maternal blood. We have also shown that the proportion of MCP-1-expressing monocytes is higher in women with vaginal delivery compared with those with caesarean delivery prior the onset of labour.
OBJECTIVES : Primary To seek link between the respective proportions of circulating maternal monocyte and lymphocyte subpopulations and the true onset of PTL characterised by delivery occurring within 7 days post admission. Secondary: to (1) compare the predictive values of these new markers with those currently used, e.g. quantification of fœtal fibronectin and assessment of cervical length and effacement, (2) Compare the respective proportions of monocytes and lymphocyte subpopulations in maternal blood and fœtal membranes, (3) determine if a correlation exists between the activation markers expressed by maternal monocyte and lymphocyte subpopulations and the neonatal outcomes of preterm infants.
Read more
MATERIAL AND METHODS: 200 patients with a singleton pregnancy between 24 and 34 weeks of amenorrhea and complicated PTL, will be prospectively included in the maternity wards of Galway (Ireland) and of Dijon with the support of the perinatal network of Burgundy. A 2X5ml blood sample will be collected upon admission, at D1, D2, D4 and D6 for women who did not deliver within the first 7 days; finally, another blood sample will be drawn upon discharge. After delivery, foetal membranes will be collected to characterize and compare the various monocyte and lymphocyte subpopulations in the maternal blood. The characterization and the study of the level of activation of blood and foetal membrane cells will be performed using flow cytometry technique with suitable markers. The main judgment criteria will be the percentage of monocytes positively expressing MCP-1 for all three monocyte subpopulations ("inflammatory", "residents or patrollers" and "intermediates", according to CD14, CD16, CCR2 and MCP-1 markers. Lymphocyte subpopulations will be assessed using the following markers: CD45, CD3, CD4, CD8 (T lymphocytes), HLA-DR (activated T lymphocytes), CD19 (B lymphocytes), CD16/CD56 (NK Cells), intracellular IFN-gamma (Th1 lymphocytes), intracellular IL-4 (Th-2 lymphocytes), intracellular IL-17 and CCR6 (Th17 lymphocytes), CD4, CD25, Foxp3 and CD127 (Tregs). Univariate statistical analysis of quantitative data will be performed using the Mann and Witney test or ANOVA, after verification of the conditions of application. The comparisons of percentages will be done using Chi-square Pearson tests and the Fisher's exact test, as appropriate. The multivariate analysis will be performed using a stepwise descending analysis.
TRANSLATIONAL DIMENSION: The characterization of the various monocyte and lymphocyte subpopulations in the maternal blood and in the foetal membranes might constitute an " immunological signature " of the labour and therefore validate the relevance of a predictive marker for clinicians.
EXPECTED RESULTS AND PERSPECTIVES: The study of the various monocyte and lymphocyte subpopulations in the maternal blood will allow to better characterise the immunological mechanisms occurring at the start of premature labour and to identity predictive markers of the preterm delivery, to validate prospectively in order to optimize the management of PTL
- Conditions
- Preterm Labour
- Being tested
- biological samples
- Keywords
- Preterm labour, monocyte, lymphocyte, MCP-1, Treg Lymphocytes, biologic markers, immunology, HLA-DR, Th17
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samplesBiological
4 blood sampling will be made at J0, J2, J4, J6 befor delivery and 1 blood sampling 3 days after delivery
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Not described Receives: Biological: biological samples |
| Volunteers | Other | Not described Receives: Biological: biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women with delivering before 7 days
Main outcome will be a delivery occurring within 7 days post admission for PTL. Women discharged from hospital before day 7 and not having delivered will not be censored; they will be classified as non-delivering before D7.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm LabourStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340222
- Sponsor's protocol ID
- SAGOT PHRC IR 2010
- Acronym
- PHENOMAP
- Status last verified
- Feb 2026
- First submitted
- 19 Apr 2011
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bardou M, Hadi T, Mace G, Pesant M, Debermont J, Barrichon M, Wendremaire M, Laurent N, Sagot P, Lirussi F. Systemic increase in human maternal circulating CD14+CD16- MCP-1+ monocytes as a marker of labor. Am J Obstet Gynecol. 2014 Jan;210(1):70.e1-9. doi: 10.1016/j.ajog.2013.08.031. Epub 2013 Aug 29.
PubMed 23994222Wendremaire M, Hadi T, Lopez TE, Guy J, Neiers F, Garrido C, Simon E, Jaffal Z, Bernigal V, Bardou M, Lirussi F. Immunophenotyping and Activation Status of Maternal Lymphocytes to Predict Spontaneous Preterm Birth in Women With Threatened Preterm Labor: A Prospective Observational Study. Am J Reprod Immunol. 2024 Dec;92(6):e70015. doi: 10.1111/aji.70015.
PubMed 39625044
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Value of Monocytes and Lymphocyte Phenotyping, Along With Intracellular MCP-1 Expression, to Predict Preterm Delivery for Women Hospitalized for Threat of Preterm Labor Between 24 and 34 Weeks of Amenorrhea: PhenoMAP Study
- ClinicalTrials.gov ID
- NCT01340222
- Acronym / sponsor ID
- PHENOMAP / SAGOT PHRC IR 2010
- Conditions
- Preterm Labour
- Keywords
- Preterm labour, monocyte, lymphocyte, MCP-1, Treg Lymphocytes, biologic markers, immunology, HLA-DR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Apr 2011 (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.
The threat of preterm labour (PTL) is the first cause of hospitalization in the course of pregnancy. Its diagnostic is based on clinical examination with a positive predictive value of about 40 %. The role of the Monocyte chemotactic protein-1 (MCP-1) in delivery has been suggested by its secretion in the amniotic fluid during labour and by the increase in the expression of its RNA messengers in the peripheral maternal blood. We have also shown that the proportion of MCP-1-expressing monocytes is higher in women with vaginal delivery compared with those with caesarean delivery prior the onset of labour.
OBJECTIVES : Primary To seek link between the respective proportions of circulating maternal monocyte and lymphocyte subpopulations and the true onset of PTL characterised by delivery occurring within 7 days post admission. Secondary: to (1) compare the predictive values of these new markers with those currently used, e.g. quantification of fœtal fibronectin and assessment of cervical length and effacement, (2) Compare the respective proportions of monocytes and lymphocyte subpopulations in maternal blood and fœtal membranes, (3) determine if a correlation exists between the activation markers expressed by maternal monocyte and lymphocyte subpopulations and the neonatal outcomes of preterm infants.
MATERIAL AND METHODS: 200 patients with a singleton pregnancy between 24 and 34 weeks of amenorrhea and complicated PTL, will be prospectively included in the maternity wards of Galway (Ireland) and of Dijon with the support of the perinatal network of Burgundy. A 2X5ml blood sample will be collected upon admission, at D1, D2, D4 and D6 for women who did not deliver within the first 7 days; finally, another blood sample will be drawn upon discharge. After delivery, foetal membranes will be collected to characterize and compare the various monocyte and lymphocyte subpopulations in the maternal blood. The characterization and the study of the level of activation of blood and foetal membrane cells will be performed using flow cytometry technique with suitable markers. The main judgment criteria will be the percentage of monocytes positively expressing MCP-1 for all three monocyte subpopulations ("inflammatory", "residents or patrollers" and "intermediates", according to CD14, CD16, CCR2 and MCP-1 markers. Lymphocyte subpopulations will be assessed using the following markers: CD45, CD3, CD4, CD8 (T lymphocytes), HLA-DR (activated T lymphocytes), CD19 (B lymphocytes), CD16/CD56 (NK Cells), intracellular IFN-gamma (Th1 lymphocytes), intracellular IL-4 (Th-2 lymphocytes), intracellular IL-17 and CCR6 (Th17 lymphocytes), CD4, CD25, Foxp3 and CD127 (Tregs). Univariate statistical analysis of quantitative data will be performed using the Mann and Witney test or ANOVA, after verification of the conditions of application. The comparisons of percentages will be done using Chi-square Pearson tests and the Fisher's exact test, as appropriate. The multivariate analysis will be performed using a stepwise descending analysis.
TRANSLATIONAL DIMENSION: The characterization of the various monocyte and lymphocyte subpopulations in the maternal blood and in the foetal membranes might constitute an " immunological signature " of the labour and therefore validate the relevance of a predictive marker for clinicians.
EXPECTED RESULTS AND PERSPECTIVES: The study of the various monocyte and lymphocyte subpopulations in the maternal blood will allow to better characterise the immunological mechanisms occurring at the start of premature labour and to identity predictive markers of the preterm delivery, to validate prospectively in order to optimize the management of PTL
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Biological: biological samples |
| Volunteers | Other | Biological: biological samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Threat of preterm labour (PTL) occurring between 24 and 34 WOA, defined according to validated criteria i.e. by (1) the presence of regular uterine contractions, lasting at least 30 seconds at a frequency ≥ 4 contractions every 30 minutes and confirmed by an external tocogram, (2) a cervical dilation of 3 cm or greater, to focus on true preterm labour, for the nulliparous women and 1-3 cm among primiparous women or multiparous and (3) a cervical obliteration >50%, or a cervix less than 25mm according to the echography, when this information is available. The first two criteria being mandatory, the third one optional as it is more subjective, or less likely to be available for every patient.
- Person who has given written consent
- Group 1: Women of reproductive age who have never had a pregnancy, even if not completed to term.
- Group 2: Single full-term, uncomplicated pregnancy (= out of hospital) older than 6 months.
Key exclusion criteria (17 listed)
- Pre-existing diabetes or gestational diabetes, morbid obesity (BMI > 35 kg/m2) as these situations modify the expression of MCP-1.
- Woman presenting a spontaneous rupture of membranes (SRM) with confirmed or probable chorioamniotitis
- Inflammatory or auto-immune disease
- Suspected or confirmed infectious disease, including HIV, HCV, HBV
- Anti-inflammatory drug treatment or immuno-modulator.
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 |
|---|---|---|
| biological samples4 blood sampling will be made at J0, J2, J4, J6 befor delivery and 1 blood sampling 3 days after delivery | Biological | Patients, Volunteers |
Primary outcome
Number of women with delivering before 7 days
Time frame: 7 days
Main outcome will be a delivery occurring within 7 days post admission for PTL. Women discharged from hospital before day 7 and not having delivered will not be censored; they will be classified as non-delivering before D7.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 23994222Bardou M, Hadi T, Mace G, Pesant M, Debermont J, Barrichon M, Wendremaire M, Laurent N, Sagot P, Lirussi F. Systemic increase in human maternal circulating CD14+CD16- MCP-1+ monocytes as a marker of labor. Am J Obstet Gynecol. 2014 Jan;210(1):70.e1-9. doi: 10.1016/j.ajog.2013.08.031. Epub 2013 Aug 29.
- Derived from this study: PubMed 39625044Wendremaire M, Hadi T, Lopez TE, Guy J, Neiers F, Garrido C, Simon E, Jaffal Z, Bernigal V, Bardou M, Lirussi F. Immunophenotyping and Activation Status of Maternal Lymphocytes to Predict Spontaneous Preterm Birth in Women With Threatened Preterm Labor: A Prospective Observational Study. Am J Reprod Immunol. 2024 Dec;92(6):e70015. doi: 10.1111/aji.70015.
Related trials for Preterm Labour
RecruitingObservational study
Cervical Stiffness in Women With Threatened Preterm Labor
Preterm Labor, Preterm Birth
Recruiting
Intravenous Papaverine for Term Prelabor Rupture of Membranes
Premature Rupture of Fetal Membranes
Recruiting
Maternal Stress on Human Milk and Infant Outcomes
Postpartum Depression, Preterm Labor
Active, not recruitingObservational study
Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?
Preterm Birth, Preterm Labor
Active, not recruitingObservational study
IL-6 and Lactates in Cord Blood and Neonatal Outcomes
Fetal Infection, Fetal Inflammatory Response Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biological samples in people with Preterm Labour, run by Centre Hospitalier Universitaire Dijon 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 9 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of women with delivering before 7 days (time frame: 7 days). 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 NCT01340222, which also lists 2 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 9 Feb 2026.