NCT00121797

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
Last Updated

November 7, 2006

Status Verified

July 1, 2005

First QC Date

July 17, 2005

Last Update Submit

November 6, 2006

Conditions

Urinary Tract Infection

Keywords

Postpartum Period

Outcome Measures

Primary Outcomes (2)

  • Rate of rehospitalization for postpartum fever

  • Incidence of UTI in the early puerperium

Interventions

urine culturePROCEDURE
antibiotics according to cultureDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parturients planned for vaginal delivery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinical microbiology, Hadassah Ein-Kerem Medical centre

Jerusalem, Israel

RECRUITING

Obs&Gyn Hadassah Ein-Kerem Medical center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Tamar Elram, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arik Tzukert, DMD

CONTACT

00 972 2 6776095arik@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2005

First Posted

July 21, 2005

Study Start

January 1, 2004

Study Completion

June 1, 2005

Last Updated

November 7, 2006

Record last verified: 2005-07

Locations

IL(2)