Peripartum Bacteruria and Urinary Tract Infections (UTI)
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Urinary Tract Infection |
Procedure: urine culture Drug: antibiotics according to culture |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI? |
- Rate of rehospitalization for postpartum fever
- Incidence of UTI in the early puerperium
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | June 2005 |
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.
Eligibility| Genders 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| Contact: Arik Tzukert, DMD | 00 972 2 6776095 | arik@hadassah.org.il |
| Contact: Hadas Lemberg, PhD | 00 972 2 6777572 | lhadas@hadassah.org.il |
| Israel | |
| Obs&Gyn Hadassah Ein-Kerem Medical center | Recruiting |
| Jerusalem, Israel | |
| Contact: David Mankuta, MD 00 972 2 6776425 mankuta@yahoo.com | |
| Sub-Investigator: David Mankuta, MD | |
| Clinical microbiology, Hadassah Ein-Kerem Medical centre | Recruiting |
| Jerusalem, Israel | |
| Contact: Mervin Shapiro, MD 00 972 2 6777111 | |
| Principal Investigator: Mervin Shapiro, MD | |
| Principal Investigator: | Tamar Elram, MD | Hadassah Medical Organization |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00121797 History of Changes |
| Other Study ID Numbers: | 26-5.9.03-HMO-CTIL, Women's health grant 8060101 |
| Study First Received: | July 17, 2005 |
| Last Updated: | November 6, 2006 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Hadassah Medical Organization:
|
Postpartum Period |
Additional relevant MeSH terms:
|
Urinary Tract Infections Infection Urologic Diseases Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012
