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

Not Applicable

Terminated

• Conditions: Patients With Spontaneous Rupture of the Fetal Membranes
• Interventions: Other: Blood samples

• Registration Number: NCT01903759
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2013-07
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-07-18
• Last Update Submitted: 2013-07-18
• Study First Posted: 2013-07-19
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 97

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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with spontaneous rupture of the fetal membranes	Blood samples	-

Primary Outcome Measures

Name	Time	Method
determination of plasma cytokines	baseline

Trial Locations

Locations (1)

CHU de Dijon; 🇫🇷 Dijon, France