Study of Cervix and Inflammation in Preterm Birth Prediction
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Preterm birth rate is 7.2% in Quebec, it's risen worldwide in the past decade and it's the
      leading cause of perinatal mortality and morbidity. Preterm birth is a major public health
      problem. Preterm labor leading to preterm birth is difficult to diagnose and prediction of
      preterm birth is a medical challenge. In the past years, research found that transvaginal
      ultrasound to assess the cervix of the uterus and vaginal detection of inflammatory protein,
      specific bacteria and fetal fibronectin can help to detect women at increase risk of preterm
      delivery. The investigators believe that a combination of these tests can lead to a better
      prediction of preterm delivery. The investigators want to conduct a study among women judged
      at increase risk of preterm delivery by their physician (having contractions, modified
      cervix, past-history of preterm delivery or multiple pregnancy) and assess their cervix by
      ultrasound and sample their vaginal secretion. The investigators want to analyze the vaginal
      sampling and look for inflammatory proteins. The objective of this study is to prove the
      feasibility of this assessment method and elaborate a better predictive test that the
      investigators can easily use in obstetrics clinics and hospitals.
    

Detailed description: 
      Preterm birth rate in Quebec is 7.2% and, despite extensive research, the rate of preterm
      birth has risen worldwide over the past decades. Preterm birth is, all over the world, the
      first cause of perinatal mortality and morbidity. Spontaneous preterm birth (sPTB) groups
      premature births with intact and ruptured membranes and represents 70% of preterm delivery.
      The two conditions associated with sPTB share a common physiopathology and a progressive
      cascade of events. Extensive evidence supports a central role for the production of
      prostaglandins, inflammatory cytokines and matrix metalloproteinases (MMP) in the cervix and
      decidua to promote cervical ripening and decidual and fetal membrane activation but, the
      exact progression of events remains unclear. Several factors were described as risk factor
      for sPTB like bacterial vaginosis, inflammatory cytokines and fetal fibronectin in vaginal
      secretions. The transvaginal ultrasound of the cervix (TVUS), which estimates the length and
      the aspect of the cervix, can be used as predictive factor of preterm birth. To date, no
      study has addressed the supra-cervical region by transvaginal ultrasound. This region may be
      an important key of the inflammatory process leading to sPTB. The assessment of this region
      by ultrasound can be a predictive marker of sPTB. We want to prove the feasibility of this
      new approach of sPTB prediction : the transvaginal ultrasound assessment of the supracervical
      and cervical region associated with detection of vaginal inflammation.
    

Intervention name(s): Transvaginal ultrasound; Vaginal secretion sampling
Intervention type(s): Procedure; Procedure
Intervention description(s): A transvaginal ultrasound with an endocavitary probe will be done as required by the medical condition of the patient. The cervical and supracervical factors will be noted.; Vaginal secretion swab will be collected each time patient will have a transvaginal ultrasound. The sample will be centrifuged, frozen and store to be analysed at the end of the study with multiplex antibody arrays.
Other intervention name(s): Ray Biotech Multiplex Antibody Arrays
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        At risk women referred by their physician to the MFM clinic for evaluation of preterm birth
        risk.
      
Biospecimen description: 
      Vaginal secretion
    
Keywords: Prematurity; Inflammation; Transvaginal ultrasound; Vaginal secretion; Inflammatory process; Neonatal morbidity