Peripartum Bacteruria and Urinary Tract Infections (UTI)
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|ClinicalTrials.gov Identifier: NCT00121797|
Recruitment Status : Unknown
Verified July 2005 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : July 21, 2005
Last Update Posted : November 7, 2006
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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?|
|Study Start Date :||January 2004|
|Estimated Study Completion Date :||June 2005|
- Rate of rehospitalization for postpartum fever
- Incidence of UTI in the early puerperium
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121797
|Contact: Arik Tzukert, DMD||00 972 2 email@example.com|
|Contact: Hadas Lemberg, PhD||00 972 2 firstname.lastname@example.org|
|Clinical microbiology, Hadassah Ein-Kerem Medical centre||Recruiting|
|Contact: Mervin Shapiro, MD 00 972 2 6777111|
|Principal Investigator: Mervin Shapiro, MD|
|Obs&Gyn Hadassah Ein-Kerem Medical center||Recruiting|
|Contact: David Mankuta, MD 00 972 2 6776425 email@example.com|
|Sub-Investigator: David Mankuta, MD|
|Principal Investigator:||Tamar Elram, MD||Hadassah Medical Organization|