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Peripartum Bacteruria and Urinary Tract Infections (UTI)

H

Hadassah Medical Center

Status

Unknown

Conditions

Urinary Tract Infection

Treatments

Procedure: urine culture
Drug: antibiotics according to culture

Study type

Interventional

Funder types

Other

Identifiers

NCT00121797
26-5.9.03-HMO-CTIL
Women's health grant 8060101

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Parturients planned for vaginal delivery

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Central trial contact

Arik Tzukert, DMD; Hadas Lemberg, PhD

Data sourced from clinicaltrials.gov

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