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Peripartum Bacteruria and Urinary Tract Infections (UTI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2005 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00121797
First Posted: July 21, 2005
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

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.


Condition Intervention
Urinary Tract Infection Procedure: urine culture Drug: antibiotics according to culture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Rate of rehospitalization for postpartum fever
  • Incidence of UTI in the early puerperium

Estimated Enrollment: 1000
Study Start Date: January 2004
Estimated Study Completion Date: June 2005
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Parturients planned for vaginal delivery

Exclusion Criteria:

  • Parturients receiving antibiotic treatment during delivery or in the week before
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121797


Contacts
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Clinical microbiology, Hadassah Ein-Kerem Medical centre Recruiting
Jerusalem, Israel
Contact: Mervin Shapiro, MD    00 972 2 6777111      
Principal Investigator: Mervin Shapiro, MD         
Obs&Gyn Hadassah Ein-Kerem Medical center Recruiting
Jerusalem, Israel
Contact: David Mankuta, MD    00 972 2 6776425    mankuta@yahoo.com   
Sub-Investigator: David Mankuta, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Tamar Elram, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00121797     History of Changes
Other Study ID Numbers: 26-5.9.03-HMO-CTIL
Women's health grant 8060101
First Submitted: July 17, 2005
First Posted: July 21, 2005
Last Update Posted: July 25, 2007
Last Verified: July 2005

Keywords provided by Hadassah Medical Organization:
Postpartum Period

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents