Clinical trial NCT01007513: Study of Cervix and Inflammation in Preterm Birth Prediction
Official title: Cervical Assessment by Supracervical, Cervical and Vaginal Markers: Simultaneous Transvaginal Ultrasound and Inflammatory Proteins Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Prematurity
Inflammation
Transvaginal ultrasound
Vaginal secretion
Inflammatory process
Neonatal morbidity
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2009-11-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Live singleton or multiple pregnancy
* Clinical risk of preterm delivery
* Pregnancy between 20 and 34 gestational weeks

Exclusion Criteria:

* Delivery on the day of the ultrasound
* Major fetal anomaly
* Previa placentation

Primary outcomes:
measure: Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study.
timeFrame: December 2009
Secondary outcomes:
measure: Presence of inflammatory proteins in vaginal secretion of patient with presence of supracervical factors at transvaginal ultrasound.
timeFrame: December 2009
measure: Neonatal morbidity of preterm infant.
timeFrame: December 2009
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: Jean-Charles Pasquier, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raiche E, Ouellet A, Berthiaume M, Rousseau E, Pasquier JC. Short and inflamed cervix predicts spontaneous preterm birth (COLIBRI study). J Matern Fetal Neonatal Med. 2014 Jul;27(10):1015-9. doi: 10.3109/14767058.2013.847917. Epub 2013 Nov 14.