Peripartum Bacteruria and Urinary Tract Infections (UTI)

NCT ID: NCT00121797

Last Updated: 2006-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infection

Keywords

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Postpartum Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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urine culture

Intervention Type PROCEDURE

antibiotics according to culture

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Parturients planned for vaginal delivery

Exclusion Criteria

* Parturients receiving antibiotic treatment during delivery or in the week before
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Tamar Elram, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Clinical microbiology, Hadassah Ein-Kerem Medical centre

Jerusalem, , Israel

Site Status RECRUITING

Obs&Gyn Hadassah Ein-Kerem Medical center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Arik Tzukert, DMD

Role: CONTACT

Phone: 00 972 2 6776095

Email: [email protected]

Hadas Lemberg, PhD

Role: CONTACT

Phone: 00 972 2 6777572

Email: [email protected]

Facility Contacts

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Mervin Shapiro, MD

Role: primary

David Mankuta, MD

Role: primary

Other Identifiers

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Women's health grant 8060101

Identifier Type: -

Identifier Source: secondary_id

26-5.9.03-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id