Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01340222
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2011-04-19
Brief Title:
Monocyte Chemotactic Protein-1 MCP-1 Expressing Monocytes to Predict Preterm Delivery PhenoMAP Study
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PHENOMAP
Brief 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 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 eg 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 CD16CD56 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 Fishers 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
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 eg 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 CD16CD56 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 Fishers 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None