Trial Outcomes & Findings for Timing of Antibiotic Prophylaxis for Cesarean Deliveries (NCT NCT00805545)
NCT ID: NCT00805545
Last Updated: 2012-04-16
Results Overview
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.
COMPLETED
NA
400 participants
Patients were followed from the time of surgery until 6 weeks postpartum.
2012-04-16
Participant Flow
Recruitment was from November 1, 2008 through November 30, 2009 on the Labor and Delivery unit at the University of Florida.
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.
Participant milestones
| Measure |
Preoperative Antibiotics
Group of patients that will receive antibiotics 30-60 minutes prior to incision
|
Post Cord-clamping Antibiotics
Group of patients that will receive antibiotics immediately after clamping the umbilical cord
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
200
|
|
Overall Study
COMPLETED
|
194
|
197
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Preoperative Antibiotics
Group of patients that will receive antibiotics 30-60 minutes prior to incision
|
Post Cord-clamping Antibiotics
Group of patients that will receive antibiotics immediately after clamping the umbilical cord
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
1
|
Baseline Characteristics
Timing of Antibiotic Prophylaxis for Cesarean Deliveries
Baseline characteristics by cohort
| Measure |
Preoperative Antibiotics
n=200 Participants
Group of patients that will receive antibiotics 30-60 minutes prior to incision
|
Post Cord-clamping Antibiotics
n=200 Participants
Group of patients that will receive antibiotics immediately after clamping the umbilical cord
|
Total
n=400 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
200 Participants
n=39 Participants
|
200 Participants
n=41 Participants
|
400 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age Continuous
|
28.04 years
STANDARD_DEVIATION 6.6 • n=39 Participants
|
28.9 years
STANDARD_DEVIATION 5.8 • n=41 Participants
|
28.9 years
STANDARD_DEVIATION 6.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
200 Participants
n=39 Participants
|
200 Participants
n=41 Participants
|
400 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=39 Participants
|
200 participants
n=41 Participants
|
400 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Preoperative Antibiotics
n=194 Participants
Group of patients that will receive antibiotics 30-60 minutes prior to incision
|
Post Cord-clamping Antibiotics
n=197 Participants
Group of patients that will receive antibiotics immediately after clamping the umbilical cord
|
|---|---|---|
|
Endometritis and Wound Infection
|
6 patients infected
Interval 0.142 to 7.28
|
4 patients infected
Interval 0.372 to 11.34
|
Adverse Events
Preoperative Antibiotics
Post Cord-clamping Antibiotics
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preoperative Antibiotics
n=200 participants at risk
Group of patients that will receive antibiotics 30-60 minutes prior to incision
|
Post Cord-clamping Antibiotics
n=200 participants at risk
Group of patients that will receive antibiotics immediately after clamping the umbilical cord
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Endometritis and wound infection
|
3.0%
6/200 • Number of events 6 • 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.
|
2.0%
4/200 • Number of events 4 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place