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.

Centre Hospitalier Universitaire Dijon1 site in 1 country97 target enrollmentSeptember 2007

ConditionsPatients With Spontaneous Rupture of the Fetal Membranes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patients With Spontaneous Rupture of the Fetal Membranes
Sponsor: Centre Hospitalier Universitaire Dijon
Enrollment: 97
Locations: 1
Primary Endpoint: determination of plasma cytokines
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

May 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Centre Hospitalier Universitaire Dijon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Term between 24 and 34 WA
•Spontaneous rupture of the fetal membranes
•Singleton pregnancy
•Age \> 18 years

Exclusion Criteria

•Delivery within the hour following admission
•Hospitalisation before 24 WA or after 34 WA
•Hemorrhagic placenta previa or retroplacental hematoma, known auto-immune or inflammatory disease
•Infection with human immunodeficiency virus (HIV)
•Refusal to provide consent.
•Patients provided for in articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g.: minors, adults under guardianship, etc...)