Peripartum Bacteruria and Urinary Tract Infections (UTI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00121797
First received: July 17, 2005
Last updated: November 6, 2006
Last verified: July 2005
  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: 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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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         
Clinical microbiology, Hadassah Ein-Kerem Medical centre Recruiting
Jerusalem, Israel
Contact: Mervin Shapiro, MD    00 972 2 6777111      
Principal Investigator: Mervin Shapiro, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Tamar Elram, MD Hadassah Medical Organization
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00121797     History of Changes
Other Study ID Numbers: 26-5.9.03-HMO-CTIL, Women's health grant 8060101
Study First Received: July 17, 2005
Last Updated: November 6, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Postpartum Period

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 18, 2014