Monitoring of the Inflammatory Response of Patients With Premature Rupture of Membranes With Bedside Tests

NCT00940043 | Completed

• 1 other identifier: 08-072
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Prematurity represents 8% of birth and it is one of the leading causes of infant complications. The preterm premature rupture of membranes (PPROM) represents one-third of preterm birth and the rupture of membranes increase the risk of fetal exposition to infection which could lead to neurological sequels. Classic management of women with PPROM before 32SA is based on the extension of the pregnancy with the risk of adding complications like a secondary infection. Moreover, different studies have shown that fetal infection could be one of the most important risk factor for subsequent neurological complications. However, it is difficult to know if it is better to extend the pregnancy to gain in maturity or to arrest the pregnancy to avoid the risk of intrauterine infection. The research objective is to suggest a new strategy to manage women with PPROM. With this new strategy, the investigators seek to extend pregnancy as much as possible but the investigators would like to give birth before the intrauterine infection. The investigators suggest detecting protein associate with neurological complications of preterm child in the amniotic liquid found in the vagina of the mother. A positive test will lead to the delivery of the newborn before its infection. The hypothesis is that it is possible to study changes in the inflammatory status of patients who presented an PPROM from repeated detection of interleukins in vaginal secretions.

Conditions

Premature Rupture of Fetal Membranes

Keywords

bedside test; interleukins; inflammation; vaginal secretions

Outcome Measures

Primary Outcomes (1)

• comparison between the results of the bedside test and the ELISA tests performed in the laboratory

  after rupture of membranes

Secondary Outcomes (1)

• description of the inflammatory status following a rupture of membranes at term and during labor

  after rupture of membranes

Study Arms (1)

Rupture of fetal membranes

women with rupture of fetal membranes before onset of labor

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women hospitalized for premature rupture of membranes at the CHUS

You may qualify if:

• Women with a single fetus and hospitalized for a rupture of membranes at term or before term.
• The criteria for diagnosis of rupture of membranes is based on clinical and biochemical tests, including Fern test and Actim PROM test

You may not qualify if:

• Twin pregnancies, patients in labor, the presence of medical complications which exclude expectant management including abruptio placentae, preeclampsia or eclampsia and fetal death.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre hospitalier de l'Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

vaginal secretions

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Inflammation

Condition Hierarchy (Ancestors)

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 hospitalier de l'Université 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: July 14, 2009
• First Posted: July 15, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

CA (1)