Study of Cervix and Inflammation in Preterm Birth Prediction

NCT01007513 | Completed

• 1 other identifier: 08-020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Prematurity; Inflammation; Transvaginal ultrasound; Vaginal secretion; Inflammatory process; Neonatal morbidity

Outcome Measures

Primary Outcomes (1)

• Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study.

  December 2009

Secondary Outcomes (2)

• Presence of inflammatory proteins in vaginal secretion of patient with presence of supracervical factors at transvaginal ultrasound.

  December 2009

• Neonatal morbidity of preterm infant.

  December 2009

Study Arms (1)

At risk patient for preterm delivery

Patient referred to the MFM clinic for a risk evaluation for preterm delivery.

Procedure: Transvaginal ultrasound; Procedure: Vaginal secretion sampling

Interventions

Transvaginal ultrasound PROCEDURE

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.

At risk patient for preterm delivery

Vaginal secretion sampling PROCEDURE

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.

Also known as: Ray Biotech Multiplex Antibody Arrays

At risk patient for preterm delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

At risk women referred by their physician to the MFM clinic for evaluation of preterm birth risk.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 24228627 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal secretion

MeSH Terms

Conditions

Premature Birth; Inflammation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Charles Pasquier, Md, PhD

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 3, 2009
• First Posted: November 4, 2009
• Study Start: June 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

CA (1)