Kinetics of Inflammation Markers in Maternal Plasma: Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes
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|ClinicalTrials.gov Identifier: NCT01903759|
Recruitment Status : Terminated
First Posted : July 19, 2013
Last Update Posted : July 19, 2013
The principal aim of this study is to help obstetricians to diagnose chorioamniotic infection early, in cases of premature rupture of the fetal membranes before 34 WA, by proposing earlier and more specific markers of infection than FBC and CRP. The aim is to reduce vital and functional risk of acute chorioamnionitis for the mother, the fetus or the newborn,.
If the kinetics profile of one or several markers correlates strongly with the diagnosis of chorioamnionitis, it could be used in clinical practice, possibly in the context of another clinical study.
The results of the study presented here are destined to be published in obstetrics journals.
|Condition or disease||Intervention/treatment||Phase|
|Patients With Spontaneous Rupture of the Fetal Membranes||Other: Blood samples||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Kinetics of Inflammation Markers in Maternal Plasma (Interleukins, Matrix Metalloproteinases -MMP): Study of the Correlation With the Diagnosis of Chorioamnionitis in Women Hospitalized for Spontaneous Rupture of the Fetal Membranes (SPROM) Before 34 Weeks of Amenorrhea (WA) With no Modification in the Usual Therapy.|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
|Patients with spontaneous rupture of the fetal membranes||
Other: Blood samples
- determination of plasma cytokines [ Time Frame: baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903759
|CHU de Dijon|
|Dijon, France, 21079|