Management of Sub-Clinical Bacteriuria in Pregnancy

Pyelonephritis Clinical Trial

Official title:

Management of Sub-Clinical Bacteriuria in Pregnancy: A Feasibility Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275623
• Other study ID #: HSC-MS-17-0294
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2017
• Est. completion date: March 18, 2019

Study information

• Verified date: March 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women who seek prenatal care within the University of Texas Health System with UT Physicians.

• Urine culture of less than 100,000 CFU

Exclusion Criteria:

• Less than 18 years of age

• Risk factors to complicated UTI (including but not limited to: diverticula, urolithiasis, renal cysts, indwelling catheter, intermittent catheterization, stent placements, nephrostomy tubes, neurogenic bladder, cystocele, vesicoureteral reflux, ileal conduit)

• Use of immunosuppressant drugs

• Abnormalities of the urinary tract (including but not limited to: known ureteric or urethral strictures, tumors of the urinary tract, pelvicalyceal obstruction, congenital anomalies, history of urological procedures)

• History of renal disease including renal failure and transplants

• Urine culture > 100,000 CFU of any organism

Related Conditions & MeSH terms

• Bacteriuria
• Cystitis
• Cystitis;Puerperium
• Pyelonephritis

Intervention

Drug:
• Antibiotic
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.

Other:
• Standard Prenatal Care
Continued surveillance of urinary cultures

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Have Cystitis	Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care.	about 10 months
Primary	Number of Participants Who Have Pyelonephritis	Pyelonephritis is defined as a urine culture with >100,000 CFU with fever at any point during antenatal care.	about 10 months