Urinary Tract InfectionNCT00121797
Peripartum Bacteruria and Urinary Tract Infections (UTI)
A study testing urine culture and antibiotics according to culture in people with Urinary Tract Infection, run by Hadassah Medical Organization at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- urine culture and antibiotics according to culture
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2004to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parturients planned for vaginal delivery
Who cannot join
- Parturients receiving antibiotic treatment during delivery or in the week before
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Clinical microbiology, Hadassah Ein-Kerem Medical centre
Jerusalem
Mervin Shapiro, MD, 00 972 2 6777111
Mervin Shapiro, MD
- Recruiting
Obs&Gyn Hadassah Ein-Kerem Medical center
Jerusalem
David Mankuta, MD, 00 972 2 6776425, mankuta@yahoo.com
David Mankuta, MD
About this study
Official title: Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?
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.
Read the 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.
- Conditions
- Urinary Tract Infection
- Being tested
- urine culture, antibiotics according to culture
- Keywords
- Postpartum Period
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine cultureProcedure or surgery
antibiotics according to cultureDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of rehospitalization for postpartum fever
Incidence of UTI in the early puerperium
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJan 2004
- Study completionJun 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Tamar Elram, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121797
- Sponsor's protocol ID
- 26-5.9.03-HMO-CTIL
- Other IDs
- Women's health grant 8060101
- Status last verified
- Jul 2005
- First submitted
- 17 Jul 2005
- Last updated
- 7 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?
- ClinicalTrials.gov ID
- NCT00121797
- Acronym / sponsor ID
- 26-5.9.03-HMO-CTIL
- Conditions
- Urinary Tract Infection
- Keywords
- Postpartum Period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Jun 2005 (estimated)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parturients planned for vaginal delivery
Key exclusion criteria (1 listed)
- Parturients receiving antibiotic treatment during delivery or in the week before
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine culture | Procedure or surgery | – |
| antibiotics according to culture | Drug | – |
Primary outcome
Rate of rehospitalization for postpartum fever
Incidence of UTI in the early puerperium
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamar Elram, MD principal investigator
Hadassah Medical Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urine culture and antibiotics according to culture in people with Urinary Tract Infection, run by Hadassah Medical Organization at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arik Tzukert, DMD (00 972 2 6776095, arik@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of rehospitalization for postpartum fever. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2006.