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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

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ClinicalTrials.gov Identifier: NCT01903759
Recruitment Status : Terminated
First Posted : July 19, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Patients With Spontaneous Rupture of the Fetal Membranes Other: Blood samples Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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.
Study Start Date : September 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Patients with spontaneous rupture of the fetal membranes Other: Blood samples



Primary Outcome Measures :
  1. determination of plasma cytokines [ Time Frame: baseline ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903759


Locations
France
CHU de Dijon
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01903759     History of Changes
Other Study ID Numbers: Sagot PHRC IR 2006
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Inflammation
Rupture
Chorioamnionitis
Rupture, Spontaneous
Pathologic Processes
Wounds and Injuries
Fetal Diseases
Pregnancy Complications
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
Pathological Conditions, Anatomical