Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic treatment | Active Comparator | Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. |
|
| No antibiotic treatment | Active Comparator | Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Akwugo A Eziefule, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Antibiotic Treatment | Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. 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. Standard Prenatal Care: Continued surveillance of urinary cultures |
| FG001 | No Antibiotic Treatment | Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Standard Prenatal Care: Continued surveillance of urinary cultures |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | No Antibiotic Treatment | Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Standard Prenatal Care: Continued surveillance of urinary cultures |
| BG001 | Antibiotic Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Have Cystitis | Cystitis is defined as a urine culture with >100,000 CFU at any point during antenatal care. | 2 participants in the "no antibiotic treatment" arm and 5 in the "antibiotic treatment" arm were not assessed for this outcome measure. | Posted | Count of Participants | Participants | about 10 months |
|
during antenatal care (about 10 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Antibiotic Treatment | Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism. Standard Prenatal Care: Continued surveillance of urinary cultures |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerrie S. Refuerzo, MD | The University of Texas Health Science Center at Houston | (713) 500-6416 | Jerrie.S.Refuerzo@uth.tmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 22, 2017 | Feb 27, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D011704 | Pyelonephritis |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Prenatal Care | Other | Continued surveillance of urinary cultures |
|
Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
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.
Standard Prenatal Care: Continued surveillance of urinary cultures
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | 2 participants in the "no antibiotic treatment" arm and 5 in the "antibiotic treatment" arm were not assessed for this outcome measure. | Posted | Count of Participants | Participants | about 10 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Antibiotic Treatment | Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism. 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. Standard Prenatal Care: Continued surveillance of urinary cultures | 0 | 30 | 0 | 30 | 0 | 30 |
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D011702 | Pyelitis |