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Inability to enroll patients at anticipated rate.
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This is a prospective randomized controlled day comparing the efficacy of three-day antimicrobial treatment of asymptomatic bacteriuria (ASB) in pregnancy to the standard seven-day treatment. Half the patients will receive 3-day treatment and the other half will receive 7 days of antibiotics.
The current standard of practice is to treat pregnant patients with ASB with a 7-day course of oral antimicrobial agents. If bacteriuria persists women are retreated with the same of different agent for a second course of 7 to 14 days and they may be subsequently placed on prophylaxis.
In nonpregnant women, an uncomplicated lower urinary tract infection may be treated with a short course regimen from 1 to 3 days. This approach has similar rates of persistent bacteriuria or symptoms following treatment when compared to women treated with a more conventional approach. If the infection recurs or persists, the patient may then be treated with the more traditional 7 to 14 day course. The advantages of single-dose regimens are cost and patient compliance, but a major disadvantage is the failure to eradicate uropathogens from the vaginal reservoir, which results in more frequent early recurrences.
The three-day regimen is advocated to maintain the advantages of lower costs and patient compliance but improving cure rates. Multiple studies have shown the advantage of even a short course of antibiotics as opposed to no treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-day treatment | Experimental | Three-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. |
|
| 7-day treatment | Active Comparator | Seven-day treatment with Cephalexin or Nitrofurantoin for diagnosis of asymptomatic bacteriuria in pregnancy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cephalexin | Drug | Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence that 3-day treatment is as effective as 7-day treatment of asymptomatic bacteriuria in pregnancy. | Comparison of percentage of women in each group with successful treatment or asymptomatic bacteriuria with negative urine culture 2 weeks after randomized treatment. | Within 21 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of development of cystitis during pregnancy. | Comparison of percentage of women in each group who develop cystitis during pregnancy and the postpartum period. | Until 6 weeks postpartum |
| The occurence of preterm delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph Mercy Hospital | Ypsilanti | Michigan | 48197 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26560337 | Background | Widmer M, Lopez I, Gulmezoglu AM, Mignini L, Roganti A. Duration of treatment for asymptomatic bacteriuria during pregnancy. Cochrane Database Syst Rev. 2015 Nov 11;2015(11):CD000491. doi: 10.1002/14651858.CD000491.pub3. | |
| 9378925 | Background | Patterson TF, Andriole VT. Detection, significance, and therapy of bacteriuria in pregnancy. Update in the managed health care era. Infect Dis Clin North Am. 1997 Sep;11(3):593-608. doi: 10.1016/s0891-5520(05)70375-5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 14, 2026 | |
| Reset | Jun 10, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 14, 2026 | Jun 10, 2026 | |||
| Jun 26, 2026 |
| ID | Term |
|---|---|
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002506 | Cephalexin |
| D009582 | Nitrofurantoin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
| Nitrofurantoin | Drug | Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection. |
|
|
Comparison of the percentage of women in each group who deliver at <37 weeks gestation.
| Assessed at the time of delivery |
| Comparison of development of pyelonephritis during pregnancy | Comparison of percentage of women in each group who develop pyelonephritis during pregnancy and the postpartum period. | Until 6 weeks postpartum |
| 2927852 | Background | Romero R, Oyarzun E, Mazor M, Sirtori M, Hobbins JC, Bracken M. Meta-analysis of the relationship between asymptomatic bacteriuria and preterm delivery/low birth weight. Obstet Gynecol. 1989 Apr;73(4):576-82. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009581 | Nitrofurans |
| D009574 | Nitro Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |