NCT01903759

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

2.7 years

First QC Date

July 17, 2013

Last Update Submit

July 18, 2013

Conditions

Patients With Spontaneous Rupture of the Fetal Membranes

Outcome Measures

Primary Outcomes (1)

  • determination of plasma cytokines

    baseline

Study Arms (1)

Patients with spontaneous rupture of the fetal membranes

OTHER
Other: Blood samples

Interventions

Blood samplesOTHER
Patients with spontaneous rupture of the fetal membranes

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Term between 24 and 34 WA
  • Spontaneous rupture of the fetal membranes
  • Singleton pregnancy
  • Age \> 18 years

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Dijon

Dijon, 21079, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 19, 2013

Study Start

September 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 19, 2013

Record last verified: 2013-07

Locations

FR(1)