Infection
Conditions
Brief 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. 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.
Interventions
DRUGAntibiotic
Cefazolin 1gm Intravenously and Azithromycin 500mg Intravenously
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* All Patients undergoing cesarean delivery
Exclusion criteria
* Patients diagnosed with chorioamnionitis at the time of decision * Patients that require an emergency cesarean delivery * Patients that decline participating on the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometritis and Wound Infection | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment was from November 1, 2008 through November 30, 2009 on the Labor and Delivery unit at the University of Florida.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Preoperative Antibiotics Group of patients that will receive antibiotics 30-60 minutes prior to incision | 200 |
| Post Cord-clamping Antibiotics Group of patients that will receive antibiotics immediately after clamping the umbilical cord | 200 |
| Total | 400 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 2 |
Baseline characteristics
| Characteristic | Post Cord-clamping Antibiotics | Preoperative Antibiotics | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 200 Participants | 200 Participants | 400 Participants |
| Age Continuous | 28.9 years STANDARD_DEVIATION 5.8 | 28.04 years STANDARD_DEVIATION 6.6 | 28.9 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 200 participants | 200 participants | 400 participants |
| Sex: Female, Male Female | 200 Participants | 200 Participants | 400 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 200 | 4 / 200 |
| serious Total, serious adverse events | 0 / 200 | 0 / 200 |
Outcome results
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.
Time frame: Patients were followed from the time of surgery until 6 weeks postpartum.
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Preoperative Antibiotics | Endometritis and Wound Infection | 6 patients infected |
| Post Cord-clamping Antibiotics | Endometritis and Wound Infection | 4 patients infected |