La. Bracero, AMPICILLIN SULBACTAM VERSUS CEFOTETAN FOR THE PREVENTION OF INFECTIONFOLLOWING CESAREAN DELIVERY IN HIGH-RISK PATIENTS - A RANDOMIZED DOUBLE-BLIND/, Gynecologic and obstetric investigation, 44(1), 1997, pp. 21-25
The objective of this study was to compare the efficacy and safety of
a single intravenous dose of 1 g ampicillin plus 0.5 g sulbactam to a
single intravenous dose of 1 g cefotetan in the prevention of postoper
ative infection following cesarean delivery in high-risk patients. In
this single-center comparative study, women who were to undergo cesare
an delivery and who were at high risk of developing postoperative infe
ction were randomized into two treatment groups. At the time the umbil
ical cord was clamped, one group was treated intravenously with 1 g am
picillin plus 0.5 g sulbactam, and the other was treated intravenously
with 1 g cefotetan. The two groups were evaluated for evidence of pos
toperative infections and adverse experiences. A total of 170 women wh
o were at high risk of developing postoperative infection following ce
sarean delivery (87 in the ampicillin/sulbactam group and 83 in the ce
fotetan group) were analyzed. Successful prophylaxis, absence of any i
nfection including absence of febrile morbidity with no other symptoms
, was reported in 69 of 87 (79%) patients receiving ampicillin/sulbact
am and in 60 of 83 (72%) patients receiving cefotetan. One patient in
each group had an infection at the incision site. There were no statis
tically significant differences in the rates of endometritis or urinar
y tract infections. The mean duration of hospitalization was 5.5 days
for patients receiving ampicillin/sulbactam and 5.7 days for patients
receiving cefotetan. A single intravenous dose of the combination of a
mpicillin/sulbactam was as safe and effective as a single intravenous
dose of cefotetan when administered for the prevention of infections f
ollowing cesarean delivery in patients at high risk of developing post
operative morbidity. Both antibiotics were safe and well tolerated wit
h no unusual or unexpected events.