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NCT00500019 Clinical Trial

Uterine Flora During Elective and Urgent Cesarean Sections

Endometritis Clinical Trial

Official title:
Uterine Flora During Elective and Urgent Cesarean Sections and Its Relationship to Postpartum Complications.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00500019
Other study ID # 1-Bornstein
Secondary ID
Status Completed
Phase N/A
First received July 11, 2007
Last updated March 30, 2009
Start date January 2005
Est. completion date September 2008

Study information
Verified date March 2009
Source Western Galilee Hospital-Nahariya
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

Hypothesis: The bacterial flora of the uterus during elective Cesarean sections differs from the uterine flora during non-elective Cesarean sections. We want to study whether the uterine flora can predict post-cesarean febrile morbidity and endometritis.

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date September 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Cesarean delivery

Exclusion Criteria:

- Vaginal delivery

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Western Galilee Hospital Nahariya

Sponsors (1)
Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare bacteriological growth between elective and non-elective cesarean section 5 years Yes
Secondary To study the various bacteria growth in the uteri, and to compare type of bacteria to post-op morbidity 5 years Yes
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