跳至主要内容
临床试验/NCT04067908
NCT04067908终止不适用

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

University Hospital, Bordeaux0 个研究点目标入组 111 人开始时间: 2011年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
111
主要终点
Premature delivery yes/no

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

woman giving birth prematurely

Experimental

Proteome: by liquid chromatography coupled with tandem mass spectrometry. Fibronectin: by vaginal sampling. Ultrasound of the cervix. Cytokines: ELISA kit of a panel of several cytokines.

干预措施: 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling (Other)

结局指标

主要结局

Premature delivery yes/no

时间窗: Premature delivery before 33 amenorrhea weeks + 6 days

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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

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