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The current standard of care to prevent post partum infectious morbidities is to administer antibiotic prophylaxis to all women undergoing a cesarean delivery. The general practice is to administer the antibiotic immediately after the umbilical cord is clamped. This study will compare the incidence of post partum infectious morbidities when the extended spectrum prophylaxis given before the incision time vs. the time of cord clamp.
Some studies suggest that administering the antibiotics prior to skin incision decrease the incidence of post partum infectious morbidities without increasing the risks to the baby from the exposure to the antibiotics. Our investigation will validate these findings in a larger series of patients. We will be conducting a prospective controlled randomized trial that will compare both methods of antibiotic prophylaxis. All patients undergoing cesarean delivery will be eligible except for the patients with the diagnosis of chorioamnionitis. One group will receive Cefazolin 1gm intravenous + Azithromycin 500mg intravenous 30-60 minutes prior to incision. The second group will receive the same antibiotics immediately after cord clamp. The primary outcomes will be endometritis, wound infection, neonatal sepsis evaluations, proven cases of neonatal infection. Secondary outcomes will be patients that required post procedure antibiotics, the duration of treatment for mother and neonate and the pattern of antibiotic resistance in microorganisms isolated and characteristics of the neonatal bowel flora.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Group of patients that will receive antibiotics 30-60 minutes prior to incision |
|
| B | Active Comparator | Group of patients that will receive antibiotics immediately after clamping the umbilical cord |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotic | Drug | Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Endometritis and Wound Infection | In non-pregnant patients having certain types of surgery with a high risk of infection, prophylactic antibiotics are routinely administered before the surgical procedure begins to ensure that a high level of antibiotic is present in tissue prior to the time that maximum bacterial contamination occurs. However, there has been concern about exposing the fetus in utero to antibiotics. The question to be addressed was whether preoperative antibiotics (as opposed to antibiotics administered after clamping of the umbilical cord) benefitted the mother without increasing risk for the baby. | Patients were followed from the time of surgery until 6 weeks postpartum. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Duff, M.D. | Obstetrics and Gynecology | Principal Investigator |
| Lorna Rodriguez, M.D. | Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shands Hospital | Gainesville | Florida | 32610 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 3118716 | Background | Duff P. Prophylactic antibiotics for cesarean delivery: a simple cost-effective strategy for prevention of postoperative morbidity. Am J Obstet Gynecol. 1987 Oct;157(4 Pt 1):794-8. doi: 10.1016/s0002-9378(87)80057-1. | |
| 18165392 | Background | Tita AT, Hauth JC, Grimes A, Owen J, Stamm AM, Andrews WW. Decreasing incidence of postcesarean endometritis with extended-spectrum antibiotic prophylaxis. Obstet Gynecol. 2008 Jan;111(1):51-6. doi: 10.1097/01.AOG.0000295868.43851.39. |
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We used computer generated random numbers to assign patients to the two groups. Patients were excluded from the study if they were allergic to either of the study drugs or if they had evidence of infection prior to surgery.
Recruitment was from November 1, 2008 through November 30, 2009 on the Labor and Delivery unit at the University of Florida.
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative Antibiotics | Group of patients that will receive antibiotics 30-60 minutes prior to incision |
| FG001 | Post Cord-clamping Antibiotics | Group of patients that will receive antibiotics immediately after clamping the umbilical cord |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative Antibiotics | Group of patients that will receive antibiotics 30-60 minutes prior to incision |
| BG001 | Post Cord-clamping Antibiotics | Group of patients that will receive antibiotics immediately after clamping the umbilical cord |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Endometritis and Wound Infection | In non-pregnant patients having certain types of surgery with a high risk of infection, prophylactic antibiotics are routinely administered before the surgical procedure begins to ensure that a high level of antibiotic is present in tissue prior to the time that maximum bacterial contamination occurs. However, there has been concern about exposing the fetus in utero to antibiotics. The question to be addressed was whether preoperative antibiotics (as opposed to antibiotics administered after clamping of the umbilical cord) benefitted the mother without increasing risk for the baby. | All 194 patients who received preoperative antibiotics and who completed the study were analyzed. All 197 patients who received post-cord clamping antibiotics and who completed the study were analyzed. | Posted | Number | 95% Confidence Interval | patients infected | Patients were followed from the time of surgery until 6 weeks postpartum. |
|
1 year
We evaluated the frequency of endometritis and wound infection in study patients. We also assessed patients for possible adverse effects related to administration of prophylatic antibiotics.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preoperative Antibiotics | Group of patients that will receive antibiotics 30-60 minutes prior to incision |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endometritis and wound infection | Pregnancy, puerperium and perinatal conditions | Other (non-serious) | Systematic Assessment | We evaluated the frequency of postoperative endometritis and wound infection in the patients who received prophylactic antibiotics. |
There were no limitations to the study. No technical problems occurred during the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Duff, M.D. | University of Florida | 352 273 7673 | duffp@ufl.edu |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Antibiotic |
| Drug |
Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously |
|
| 16722001 | Background | Burke JF. The effective period of preventive antibiotic action in experimental incisions and dermal lesions. Surgery. 1961 Jul;50:161-8. |
| 17466699 | Background | Sullivan SA, Smith T, Chang E, Hulsey T, Vandorsten JP, Soper D. Administration of cefazolin prior to skin incision is superior to cefazolin at cord clamping in preventing postcesarean infectious morbidity: a randomized, controlled trial. Am J Obstet Gynecol. 2007 May;196(5):455.e1-5. doi: 10.1016/j.ajog.2007.03.022. |
| 418966 | Background | Gordon HR, Phelps D, Blanchard K. Prophylactic cesarean section antibiotics: maternal and neonatal morbidity before or after cord clamping. Obstet Gynecol. 1979 Feb;53(2):151-6. |
| 6866355 | Background | Cunningham FG, Leveno KJ, DePalma RT, Roark M, Rosenfeld CR. Perioperative antimicrobials for cesarean delivery: before or after cord clamping? Obstet Gynecol. 1983 Aug;62(2):151-4. |
| 15970833 | Background | Thigpen BD, Hood WA, Chauhan S, Bufkin L, Bofill J, Magann E, Morrison JC. Timing of prophylactic antibiotic administration in the uninfected laboring gravida: a randomized clinical trial. Am J Obstet Gynecol. 2005 Jun;192(6):1864-8; discussion 1868-71. doi: 10.1016/j.ajog.2004.12.063. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Group of patients that will receive antibiotics 30-60 minutes prior to incision |
| OG001 | Post Cord-clamping Antibiotics | Group of patients that will receive antibiotics immediately after clamping the umbilical cord |
|
|
| 0 |
| 200 |
| 6 |
| 200 |
| EG001 | Post Cord-clamping Antibiotics | Group of patients that will receive antibiotics immediately after clamping the umbilical cord | 0 | 200 | 4 | 200 |
|
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