- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00500019
Uterine Flora During Elective and Urgent Cesarean Sections
Uterine Flora During Elective and Urgent Cesarean Sections and Its Relationship to Postpartum Complications.
Study Overview
Status
Conditions
Detailed Description
Objective: To evaluate the uterine flora at the time of elective and non-elective cesarean sections and to study the relationship to the development of postpartum fever and/or endometritis.
Methods: Eight-hundred women who will be delivered by cesarean section will be enrolled in this study. Cultures will be obtained during the surgery from the open uterine cavity after removal of the placenta. Data regarding postpartum morbidity would be collected.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Nahariya, Israel, 22100
- Western Galilee Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cesarean delivery
Exclusion Criteria:
- Vaginal delivery
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
1.
Elective Cesarean sections
|
2.
Non-elective cesarean section
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare bacteriological growth between elective and non-elective cesarean section
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To study the various bacteria growth in the uteri, and to compare type of bacteria to post-op morbidity
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-Bornstein
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