Peripartum Bacteruria and Urinary Tract Infections (UTI)
Primary Purpose
Urinary Tract Infection
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
urine culture
antibiotics according to culture
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infection focused on measuring Postpartum Period
Eligibility Criteria
Inclusion Criteria: Parturients planned for vaginal delivery Exclusion Criteria: Parturients receiving antibiotic treatment during delivery or in the week before
Sites / Locations
- Clinical microbiology, Hadassah Ein-Kerem Medical centreRecruiting
- Obs&Gyn Hadassah Ein-Kerem Medical centerRecruiting
Outcomes
Primary Outcome Measures
Rate of rehospitalization for postpartum fever
Incidence of UTI in the early puerperium
Secondary Outcome Measures
Full Information
NCT ID
NCT00121797
First Posted
July 17, 2005
Last Updated
November 6, 2006
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00121797
Brief Title
Peripartum Bacteruria and Urinary Tract Infections (UTI)
Official Title
Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2005
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
Brief Summary
In the last years urinary tract infections (UTI) and pyelonephritis have been the most common reason for readmission to our hospital after birth. UTI is know to be one of the leading causes of postpartum fever affecting about 3%-8% of all postpartum women.
The investigators hypothesize that collecting urine cultures pre- and postnatally may help identify women at risk for developing UTI, while treating women with positive cultures could decrease the rehospitalization rate due to postpartum fever. Collecting data during delivery may help identify women at risk for this complication.
Detailed Description
The study is planned as a randomized controlled study with 500 women in each arm. The study group will have pre and post labor urine cultures taken, and the risk factors during delivery will be documented, while the control group will have no cultures taken, as the common practice prior to the study.
Women with positive cultures will be contacted by telephone, and antibiotic treatment recommended according to bacteria sensitivity. All women will be contacted by telephone 1 month post partum and data regarding urinary tract symptoms and need for hospitalization, will be collected. The rehospitalization rate will be documented and compared between the two groups.
The assumption is that routine urine culture to women in the peripartum period may reduce the UTI rate and hospitalization after delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Postpartum Period
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
urine culture
Intervention Type
Drug
Intervention Name(s)
antibiotics according to culture
Primary Outcome Measure Information:
Title
Rate of rehospitalization for postpartum fever
Title
Incidence of UTI in the early puerperium
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parturients planned for vaginal delivery
Exclusion Criteria:
Parturients receiving antibiotic treatment during delivery or in the week before
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamar Elram, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical microbiology, Hadassah Ein-Kerem Medical centre
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mervin Shapiro, MD
Phone
00 972 2 6777111
First Name & Middle Initial & Last Name & Degree
Mervin Shapiro, MD
Facility Name
Obs&Gyn Hadassah Ein-Kerem Medical center
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Mankuta, MD
Phone
00 972 2 6776425
Email
mankuta@yahoo.com
First Name & Middle Initial & Last Name & Degree
David Mankuta, MD
12. IPD Sharing Statement
Learn more about this trial
Peripartum Bacteruria and Urinary Tract Infections (UTI)
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