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Clinical Trial Summary

Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality.

This study aims to estimate the prognostic value of new biomarkers (proteomic markers) on the occurrence of preterm birth.


Clinical Trial Description

Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. With 7.2% of premature deliveries in France, threat of premature labor remains the leading cause of maternal transfer and hospitalization. In terms of mortality, morbidity and cost, the fight against prematurity remains a national priority in terms of public health.

The diagnosis of threat of premature labor at high risk of preterm labor is difficult and clinical and laboratory criteria often remain insufficient. Measurement of the cervix by endovaginal ultrasound lacks sensitivity and specificity. Among the biological criteria, only fibronectin, which has a good negative predictive value, is used in current practice. Despite the use of these two prognostic criteria, only 40% of hospitalized patients will give birth prematurely.

Recent advances in proteomics allow us to study complex proteomes and compare them. Preliminary studies already carried out have revealed families of proteins expressed differently in situations of work or premature delivery. We therefore hypothesize that the study of a woman's vaginal proteome with threat of premature labor may reveal new markers of preterm labor. These markers could help the clinician in its therapeutic management and thus reduce hospitalizations, better target patients requiring tocolytic treatment and optimize the use of corticosteroids. In addition, variations in the proteome may help to understand the physiopathological mechanisms of premature delivery, which are necessary for the development of effective therapeutics. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04067908
Study type Interventional
Source University Hospital, Bordeaux
Contact
Status Completed
Phase N/A
Start date June 7, 2011
Completion date December 28, 2013

See also
  Status Clinical Trial Phase
Recruiting NCT02904070 - Interest of Placental Alpha-microglobulin-1 Detection Test to Assess Risk of Premature Delivery in Reunion Island Phase 4
Terminated NCT01977079 - Procalcitonin and Threatened Premature Delivery N/A
Withdrawn NCT02859298 - Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery. N/A
Not yet recruiting NCT06349122 - Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth Phase 4