Monitoring of the Inflammatory Response of Patients With Premature Rupture of Membranes With Bedside Tests (EFFARM)
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|ClinicalTrials.gov Identifier: NCT00940043|
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : January 16, 2013
|Condition or disease|
|Premature Rupture of Fetal Membranes|
Preterm premature rupture of the membranes (PPROM) represents one-third of preterm births and is the leading cause of perinatal mortality and morbidity. During the latency period, several events such as the ascent of pathogenic microorganisms from the lower genital area could create complications which may culminate in cerebral palsy. Avoiding intrauterine infection appears as one of the most important objective in the PPROM management. Most authors propose the conservative management of women with PPROM, associating antibiotic therapy to corticosteroid administration in patients with PPROM before 30 to 32 weeks. The main benefit of conservative management is prolonging pregnancy, but the benefit must be balanced with the risks of fetal complications. In an effort to diminish the risks of infection linked to a longer latency period, several authors have proposed intentional delivery after PPROM.
The primary objective is the comparison between the results of IMMUNOCHROMATOGRAPHY tests done at the bedside of the patient and the ELISA tests performed in the laboratory.
The secondary outcome is the description of the inflammatory status following a rupture of membranes at term and during labor.
Vaginal secretions samplings are perform after premature rupture of membranes and during labor. The bedside test is performing immediately after sampling and the rest of the sampling is frozen. ELISA assays will be performed on these samples.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Monitoring of Women With Preterm Premature Rupture of Membranes (PPROM) Between 28 and 33 Weeks of Gestation With Repetitive Immunochromatographic Bedside Test to Detect Inflammatory Protein in Vaginal Secretions.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||December 2009|
Rupture of fetal membranes
women with rupture of fetal membranes before onset of labor
- comparison between the results of the bedside test and the ELISA tests performed in the laboratory [ Time Frame: after rupture of membranes ]
- description of the inflammatory status following a rupture of membranes at term and during labor [ Time Frame: after rupture of membranes ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940043
|Centre hospitalier de l'Université de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Jean-Charles Pasquier, MD, PhD||Centre hospitalier de l'Université de Sherbrooke|