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

Patients With Spontaneous Rupture of the Fetal Membranes Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01903759
• Other study ID #: Sagot PHRC IR 2006
• Status: Terminated
• Phase: N/A
• First received: July 17, 2013
• Last updated: July 18, 2013
• Start date: September 2007
• Est. completion date: May 2010

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chorioamnionitis
• Patients With Spontaneous Rupture of the Fetal Membranes
• Rupture
• Rupture, Spontaneous

Intervention

Other:
• Blood samples

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determination of plasma cytokines		baseline	No