A Phase 4 interventional study of Antibiotic and Standard Prenatal Care in Cystitis, Cystitis;Puerperium and Pyelonephritis, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-03.
Sponsored by The University of Texas Health Science Center, Houston · Phase 4, Interventional, and Treatment
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.
69 studies on the registry are indexed under Cystitis; 17 are open to participants now.
This study's enrollment of 60 is below the median of 112 across 50 interventional studies indexed under Cystitis.
Browse Cystitis studies →The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard prenatal care with treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Drug: Antibiotic · Other: Standard Prenatal Care
Standard prenatal care without treatment for any urine culture with growth of 1- 100,000 CFU of any organism.
Other: Standard Prenatal Care
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.
Continued surveillance of urinary cultures
Number of Participants Who Have Cystitis
Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care.
Time frame: 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.
Time frame: about 10 months
| Milestone | Antibiotic Treatment | No Antibiotic Treatment |
|---|---|---|
| Started | 30 | 30 |
| Completed | 25 | 28 |
| Not completed | 5 | 2 |
Cystitis is defined as a urine culture with \>100,000 CFU at any point during antenatal care.
| Participants | No Antibiotic Treatment | Antibiotic Treatment |
|---|---|---|
| Number of Participants Who Have Cystitis | 4 | 4 |
Pyelonephritis is defined as a urine culture with \>100,000 CFU with fever at any point during antenatal care.
| Participants | No Antibiotic Treatment | Antibiotic Treatment |
|---|---|---|
| Number of Participants Who Have Pyelonephritis | 3 | 4 |
Collected over during antenatal care (about 10 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Antibiotic Treatment | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Antibiotic Treatment | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Customized(Participants) | No Antibiotic Treatment | Antibiotic Treatment | Total |
|---|---|---|---|
| <20 | 6 | 11 | 17 |
| 20-34 | 19 | 12 | 31 |
| >=35 | 5 | 7 | 12 |
| Sex: Female, Male(Participants) | No Antibiotic Treatment | Antibiotic Treatment | Total |
|---|---|---|---|
| Female | 30 | 30 | 60 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | No Antibiotic Treatment | Antibiotic Treatment | Total |
|---|---|---|---|
| Black | 17 | 15 | 32 |
| Hispanic | 4 | 9 | 13 |
| White | 5 | 4 | 9 |
| Other | 4 | 2 | 6 |
| Region of Enrollment(Participants) | No Antibiotic Treatment | Antibiotic Treatment | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2017 to primary completion in Mar 2019, 18 months.
Results were first posted in Apr 2020, 1 year after primary completion.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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