Clinical trial NCT04067908: New Biomarkers Associated With the Risk of Premature Delivery.
Official title: Study of New Biomarkers Associated With the Risk of Premature Delivery During Spontaneous Work With Intact Membranes Before 37 Weeks of Amenorrhea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Delivery
Keywords: Biological markers
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 182
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Premature delivery yes/no
timeFrame: Premature delivery before 33 amenorrhea weeks + 6 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Dominique DALLAY, Pr
role: PRINCIPAL_INVESTIGATOR
References: