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| Tracking Information | |||||||||
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| First Received Date † | July 17, 2005 | ||||||||
| Last Updated Date | November 6, 2006 | ||||||||
| Start Date † | January 2004 | ||||||||
| Current Primary Outcome Measures † |
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| Original Primary Outcome Measures † |
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| Change History | Complete list of historical versions of study NCT00121797 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † | |||||||||
| Original Secondary Outcome Measures † | |||||||||
| Descriptive Information | |||||||||
| Brief Title † | Peripartum Bacteruria and Urinary Tract Infections (UTI) | ||||||||
| Official Title † | Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI? | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Open Label, Historical Control, Parallel Assignment | ||||||||
| Condition † | Urinary Tract Infection | ||||||||
| Intervention † |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 1000 | ||||||||
| Estimated Completion Date | June 2005 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | Israel | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00121797 | ||||||||
| Responsible Party | |||||||||
| Secondary IDs †† | Women's health grant 8060101 | ||||||||
| Study Sponsor † | Hadassah Medical Organization | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | Hadassah Medical Organization | ||||||||
| Verification Date | July 2005 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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