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

NCT ID: NCT01903759

Last Updated: 2013-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Patients With Spontaneous Rupture of the Fetal Membranes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Patients with spontaneous rupture of the fetal membranes

Group Type OTHER

Blood samples

Intervention Type OTHER

Interventions

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Blood samples

Intervention Type OTHER

Eligibility Criteria

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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…)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Dijon

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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Sagot PHRC IR 2006

Identifier Type: -

Identifier Source: org_study_id

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