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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2010

Interventions

  • Other: Blood samples

Arms, Groups and Cohorts

  • Other: Patients with spontaneous rupture of the fetal membranes

Clinical Trial Outcome Measures

Primary Measures

  • determination of plasma cytokines
    • Time Frame: baseline

Participating in This Clinical Trial

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…)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire Dijon
  • Provider of Information About this Clinical Study
    • Sponsor

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