InfectionNCT00805545
Timing of Antibiotic Prophylaxis for Cesarean Deliveries
A study testing Antibiotic in people with Infection, run by University of Florida at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Antibiotic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Patients undergoing cesarean delivery
Who cannot join
- Patients diagnosed with chorioamnionitis at the time of decision
- Patients that require an emergency cesarean delivery
- Patients that decline participating on the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Timing of Antibiotic Prophylaxis for Cesarean Delivery
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.
Read the detailed description
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.
- Conditions
- Infection
- Being tested
- Antibiotic
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously
AntibioticDrug
Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Group of patients that will receive antibiotics 30-60 minutes prior to incision Receives: Drug: Antibiotic |
| B | Active comparator | Group of patients that will receive antibiotics immediately after clamping the umbilical cord Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients were followed from the time of surgery until 6 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Duff, M.D., Principal investigator, Obstetrics and GynecologyLorna Rodriguez, M.D., Principal investigator, Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805545
- Sponsor's protocol ID
- C/S- Antibiotics
- Status last verified
- Mar 2012
- First submitted
- 5 Dec 2008
- Last updated
- 16 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 3118716Tita 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.
PubMed 18165392Burke JF. The effective period of preventive antibiotic action in experimental incisions and dermal lesions. Surgery. 1961 Jul;50:161-8.
PubMed 16722001Sullivan 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.
PubMed 17466699Gordon 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.
PubMed 418966Cunningham 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.
PubMed 6866355Thigpen 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.
PubMed 15970833
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Timing of Antibiotic Prophylaxis for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT00805545
- Acronym / sponsor ID
- C/S- Antibiotics
- Conditions
- Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Posted 16 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AntibioticGroup of patients that will receive antibiotics 30-60 minutes prior to incision |
| B | Active comparator | Drug: AntibioticGroup of patients that will receive antibiotics immediately after clamping the umbilical cord |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All Patients undergoing cesarean delivery
Key exclusion criteria (3 listed)
- Patients diagnosed with chorioamnionitis at the time of decision
- Patients that require an emergency cesarean delivery
- Patients that decline participating on the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticCefazolin 1gm Intravenously and Azithromycin 500mg Intravenously | Drug | A |
| AntibioticCefazolin 1gm Intravenously and Azithromycin 500mg Intravenously | Drug | B |
Primary outcome
Endometritis and Wound Infection
Time frame: Patients were followed from the time of surgery until 6 weeks postpartum.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 3118716Duff 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.
- Background: PubMed 18165392Tita 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.
- Background: PubMed 16722001Burke JF. The effective period of preventive antibiotic action in experimental incisions and dermal lesions. Surgery. 1961 Jul;50:161-8.
- Background: PubMed 17466699Sullivan 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.
- Background: PubMed 418966Gordon 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.
- Background: PubMed 6866355Cunningham 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.
- Background: PubMed 15970833Thigpen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Duff, M.D. principal investigator
Obstetrics and Gynecology
Lorna Rodriguez, M.D. principal investigator
Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic in people with Infection, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometritis and Wound Infection (time frame: Patients were followed from the time of surgery until 6 weeks postpartum.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00805545, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2012.