Peripartum Bacteruria and Urinary Tract Infections (UTI)

Urinary Tract Infection Clinical Trial

Official title:

Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00121797
• Other study ID #: 26-5.9.03-HMO-CTIL
• Secondary ID: Women's health g
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2005
• Last updated: November 6, 2006
• Start date: January 2004
• Est. completion date: June 2005

Study information

• Verified date: July 2005
• Source: Hadassah Medical Organization
• Contact: Arik Tzukert, DMD
• Phone: 00 972 2 6776095
• Email: arik[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parturients planned for vaginal delivery

Exclusion Criteria:

• Parturients receiving antibiotic treatment during delivery or in the week before

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Procedure:
• urine culture

Drug:
• antibiotics according to culture

Locations

Country	Name	City	State
Israel	Clinical microbiology, Hadassah Ein-Kerem Medical centre	Jerusalem
Israel	Obs&Gyn Hadassah Ein-Kerem Medical center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of rehospitalization for postpartum fever
Primary	Incidence of UTI in the early puerperium