New Biomarkers Associated With the Risk of Premature Delivery.

Premature Delivery Clinical Trial

— PROTEOMAP  

Official title:

Study of New Biomarkers Associated With the Risk of Premature Delivery During Spontaneous Work With Intact Membranes Before 37 Weeks of Amenorrhea.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067908
• Other study ID #: CHUBX 2010/19
• Status: Completed
• Phase: N/A
• Start date: June 7, 2011
• Est. completion date: December 28, 2013

Study information

• Verified date: August 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 28, 2013
• Est. primary completion date: December 28, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women over 18 years of age

• Term from 22 to 33 and 6 amenorrhea weeks

• Single or twin pregnancy

• Emergency consultant, in participating centers, for a threat of premature labor defined by:

Uterine contractions greater than or equal to 3 in 30 minutes Clinical modification of the cervix Ultrasound collar less than 25 mm

• Free, informed and written consent, dated and signed by the patient and the investigator before any investigation required by the research.

• Patient affiliated to a Social Security scheme.

Exclusion Criteria:

• Premature rupture of membranes

• Placenta previa

• Vaginal haemorrhage at the time of sampling

• Uterine malformation

• Strapping, open bite

• History of strapping and or open bite

• Conization

• Fetal malformation

• Associated vasorenal pathology

• Sexual intercourse less than 24h

• Gynecological examination less than 48h

• Vaginal treatment in progress

• Polyhydramnios

• Transfused-transfused syndrome

• Twin Anemia Polycythemia syndrome

• Fetoscopy during pregnancy

Related Conditions & MeSH terms

• Premature Birth
• Premature Delivery

Intervention

Other:
• 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling
The samples taken during this study are taken at the same time as those taken in routine during the diagnosis of threat of premature labor. There are added 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature delivery yes/no	Premature labor is defined as a pregnancy duration of less than 37 weeks. For this study, cases of interest are : premature labor before 33 amenorrhea weeks + 6 days.	Premature delivery before 33 amenorrhea weeks + 6 days