CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Antibiotic +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03275623
NCT03275623Phase 4Completed
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Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial

The University of Texas Health Science Center, Houston·interventional·Posted Sep 7, 2017·Updated Apr 3, 2020

In Brief

A Phase 4 clinical trial evaluating Antibiotic and Standard Prenatal Care for Cystitis and 2 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purpose of the study is to determine if treatment of pregnant women with urine cultures with a low level of bacteria (less than 100,000 colony forming units (CFU)) may decrease adverse pregnancy outcomes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystitis, Cystitis;Puerperium, Pyelonephritis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedSep 7, 2017
Enrollment StartSep 15, 2017
Primary CompletionMar 18, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.8 years ago

Interventions

Antibioticdrug

Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.

Standard Prenatal Careother

Continued surveillance of urinary cultures