Peripartum Bacteruria and Urinary Tract Infections (UTI)

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00121797
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 2
• Duration (Months): 17
• Patients Per Site: 500
• Patients Per Site Per Month: 29.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Procedure: urine culture; Drug: antibiotics according to culture	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?
• Study Start Date: Jan 1, 2004
• Anticipated Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

1. Rate of rehospitalization for postpartum fever []

2. Incidence of UTI in the early puerperium []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Parturients planned for vaginal delivery

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical microbiology, Hadassah Ein-Kerem Medical centre	Jerusalem		Israel
2	Obs&Gyn Hadassah Ein-Kerem Medical center	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

• Principal Investigator: Tamar Elram, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00121797
• Other Study ID Numbers: 26-5.9.03-HMO-CTIL; Women's health grant 8060101
• First Posted: Jul 21, 2005
• Last Update Posted: Nov 7, 2006
• Last Verified: Jul 1, 2005

• Keywords provided by , ,: Postpartum Period
• Additional relevant MeSH terms: Infections; Urinary Tract Infections; Anti-Bacterial Agents

Study Results

No Results Posted as of Nov 7, 2006