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Trial NCT00940043

Resource URI: http://static.linkedct.org/resource/trials/NCT00940043
linkedct:acronym EFFARM
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/60087>
linkedct:biospec vaginal secretions
linkedct:biospec_retention Samples Without DNA
linkedct:brief_title Monitoring of the Inflammatory Response of Patients With Premature Rupture of Membranes With Bedside Tests
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/17022>
linkedct:criteria Inclusion Criteria: - 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 Exclusion Criteria: - Twin pregnancies, patients in labor, the presence of medical complications which exclude expectant management including abruptio placentae, preeclampsia or eclampsia and fetal death.
linkedct:description 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 40 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:eligibility_sampling_method Non-Probability Sample
linkedct:eligibility_study_pop women hospitalized for premature rupture of membranes at the CHUS
linkedct:end_date September 2009
linkedct:enrollment 60 (xsd:int)
linkedct:firstreceived_date July 14, 2009
linkedct:has_dmc No
linkedct:id NCT00940043
rdfs:label Trial NCT00940043
linkedct:lastchanged_date July 14, 2009
linkedct:lead_sponsor_agency Universitaire de Sherbrooke
linkedct:location <http://static.linkedct.org/resource/location/263700>
linkedct:nct_id NCT00940043
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 1 (xsd:int)
linkedct: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.
linkedct:org_study_id 08-072
linkedct:overall_contact_email llavoie.chus@ssss.gouv.qc.ca
linkedct:overall_contact_last_name Lise Lavoie
linkedct:overall_contact_phone 819-346-1110
linkedct:overall_contact_phone_ext 13879
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/26430>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/402>
foaf:page <http://clinicaltrials.gov/show/NCT00940043>
linkedct:phase N/A
linkedct:primary_completion_date August 2009
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/52291>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/33179>
linkedct:source Universitaire de Sherbrooke
linkedct:start_date September 2008
linkedct:study_design Cohort, Prospective
linkedct:study_type Observational
linkedct: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, we seek to extend pregnancy as much as possible but we 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.
rdf:type linkedct:trials
linkedct:verification_date July 2009