NCT00500019

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

First QC Date

July 11, 2007

Last Update Submit

March 30, 2009

Conditions

Endometritis

Outcome Measures

Primary Outcomes (1)

  • To compare bacteriological growth between elective and non-elective cesarean section

    5 years

Secondary Outcomes (1)

  • To study the various bacteria growth in the uteri, and to compare type of bacteria to post-op morbidity

    5 years

Study Arms (2)

1.

Elective Cesarean sections

2.

Non-elective cesarean section

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing cesarean sections in Western galilee Hospital

You may qualify if:

  • Cesarean delivery

You may not qualify if:

  • Vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Galilee Hospital

Nahariya, 22100, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Uterine bacteriological cultures

MeSH Terms

Conditions

Endometritis

Condition Hierarchy (Ancestors)

Pelvic Inflammatory DiseaseAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUterine DiseasesGenital Diseases

Study Officials

  • Ido Solt, MD

    Western Galilee Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 11, 2007

First Posted

July 12, 2007

Study Start

January 1, 2005

Study Completion

September 1, 2008

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

IL(1)