Antibiotic for cesarean section: the case for ‘true’ prophylaxis

Antibiotic for cesarean section: the case for ‘true’ prophylaxis

Int J Gynecol Obstet, International Federation 1993, 43: 257-261 of Gynecology 257 and Obstetrics Antibiotic for cesarean section: the case fo...

437KB Sizes 14 Downloads 108 Views

Int J Gynecol

Obstet,

International

Federation

1993, 43: 257-261

of Gynecology

257

and Obstetrics

Antibiotic for cesarean section: the case for ‘true’ prophylaxis M.D. Fejgin, Department Medical

S. Markov,

of Obstetrics

School

and Gynecology

S. Goshen, and the Division

J. Segal, Y. Arbel and R. Lang of Iqfectious

Diseases. Muir

Hospital.

Kfur Suhu.and

Tel Aviv

Unirer.ritv

(Israel)

(Received June 7th. 1993) (Revised and accepted August

IOth, 1993)

Abstract

Keywords: Prophylaxis; Antibiotics.

OBJECTIVES: To assess prospectively the efficiency and safety of two extended spectrum cephlosporins used as pre-operative prophylaxis in nonelective cesarean sections, and compare the results to those of a third group of patients that received cefamezine post cord clamping. METHODS: Two hundred and forty one patients undergoing a nonscheduled cesarean section were assigned to receive either cefonicid or ceftriaxone prior to skin incision. These patients were followed prospectively for infectious and fetal complications. The outcome of these patients was also compared with another group of 194 patients that received cefamezine prophylaxis post cord clamping, and whose data were collected retrospectively. Chi-square analysis of variance were performed with P < 0.05 considered significant. RES UL TS: There were no significant differences in the febrile complications among the two groups of patients that received pre-operative prophylaxis. However, these patients had significantly less wound infections (P = 0.008) and a significantly shorter hospital stay (P < 0.001) than the patients who received their prophylactic antibiotics post cord clamping. CONCLUSIONS: Extended-spectrum cephalosporins, when given pre-operatively, are both effective and safe, and may have an advantage over intra-operative first generation cephalosporins in the reduction of post cesarean section infectious morbidity.

Introduction

0020-7293/93/%06.00 0 1993 International Federation Printed and Published in Ireland

A short course of prophylactic antibiotics for emergency cesarean section, has proven to be effective in reducing postoperative febrile morbidity. Since the early 1970s in most institutions the antibiotics have been administrated following cord clamping. The reasoning for this routine was the concern about the antibiotics reaching the newborn. However, this approach is not considered ‘true prophylaxis,’ since the antibiotics are not present in the tissues at the time the incision is made [ 131. This may explain the fact, that in spite of the use of antibiotics, infectious complications of emergency cesarean sections are quite high, and occurs in about 20% of the patients [2,4,11]. Recently, there is a tendency to use extended spectrum cephalosporins for prophylaxis, although there is no clinical proof of their advantage [ 1,3]. The purpose of this was to evaluate the effectiveness and safety of two extended cephalosporins that were given pre-operatively, as compared to a first generation cephalosporin which was given post-cord clamping. Materials and methods We studied prospectively the clinical outcome of patients that received a single dose of either cefonicid or ceftriaxone prior to an Article

of Gynecology

and Obstetrics

258

Fejgin el al,

emergency cesarean section. In addition, we compared the cumulative results of the two groups to the outcome of another group of patients in the same institution, who had received three doses of a lirst generation cephalosporin, the first one given post-cord clamping. The data of this third group were collected retrospectively. All afebrile patients undergoing an emergency (non-scheduled) cesarean section at Meir Hospital, Israel, during the years 1988-89, were included in the study. The patients were randomly assigned (based on the last digit of their ID number), to one of the following groups: Group 1 (125 patients) received cefonicid (cef 1). and group 2 (116 patients), received ceftriaxone (cef 2). One gram of the assigned antibiotics was given intravenously, upon decision to perform the operation, and after obtaining a written consent. A placebo group was not used because of the ample support in the literature for the use of prophylaxis in emergency cesarean sections. Surgery was usually performed by a resident, assisted by an attending physician. Epidural block was the anesthesia of choice, and was used in most cases. All patients had an indwelling Foley catheter for 12-24 h. Following surgery, the patients were observed for clinical signs of infection. Febrile morbidity was defined as an oral temperature above 38°C in two consecutive readings, excluding the first 24 h. The patients who developed postoperative fever underwent a thorough physical examination. Laboratory workup included: complete blood count, urine, blood and cervical-endometrial cultures. The diagnosis of endometritis was based on the findings of uterine tenderness and foul smelling lochia. When the diagnosis of a wound infection was made, based on the presence of cellulitis and purulent discharge from the incision, wound cultures were also taken. A urinary tract infection was diagnosed based on the growth of 100 colonies or more, from a catheterized urine sample. Positive blood cultures were required for the diagnosis of bacteremia. Int J Gynecol Obstet 43

All newborns were observed in the nursery for the duration of their mothers’ hospitalization. In addition, a telephone survey was conducted on a sample of the newborns for late complications. The clinical outcome of these two groups was compared. The results of these two groups were pooled together, and compared to a third group of patients (194 patients), who were operated at our department during the years 1986-87, and who received cefazolin in the following manner: 1 g i.v. after cord clamping, and two additional doses of 1 g, 6 h apart. The clinical results of the latter group were collected retrospectively. Although this information came from earlier years, we were able to use it since no other changes in the practice management of cesarean sections occurred between the earlier period and the prospective study period. Chi-square and analysis of variance were performed using the Statistical Package for the Social Science program (SPSS, Inc, Chicago, IL), with P < 0.05 considered significant. The study was approved by a special Committee that included a neonatologist and an infectious diseases consultant. Results

The preoperative and operative information of groups 1 and 2 was compared. There was no significant difference in the length of gestation, the number of obese patients, the incidence of premature rupture of the membranes, the length of labor, the number of pelvic examinations, and the indications for the cesarean section between the two groups. Also, the length of the operation was not significantly different. Table 1 presents the febrile complications of the two groups. The incidence of fever in group 1 was higher than group 2 (16 vs. 13.7X), however, this difference was not significant, nor was there any significant difference in the other infectious complications. There was a relatively high incidence of unexplained fever, beyond the first 24 h, in both groups,

Table I.

Febrile

morbidity.

Fever Temp (mean “C) Duration fever (days) UT1 Pneumonia Endometritis Wound infection Septicemia Phlebitis Other Unexplained Length stay (days) Fetal Sepsis

Table 3. Group I (n = 125)

Group

20( 16%) 38.57 2.9 3

16(13.7’%1) 38.38 2.18

I

(n=

P

2

116)

I 0

I

3

I

0

I

0

I

0

3 9 6.31 0

2 8 6.22 0

ns. n.s. n.s. ns. n.s. ns. n.s. n.s. ns. n.s.

Fever Temp (mean “C) Duration fever (days) UT1 Pneumonia Endometritis Wound infection Septicemia Phlebitis Other

ns. n.s.

Length stay (days) Fetal sepsis

half of them not requiring additional antibiotic treatment. The length of hospital stay was also similar. None of the newborns developed sepsis. The preoperative and operative clinical information of the newly created group of 241 patients (group 1 and 2 pooled together) differed statistically from group 3 only in two aspects: the incidence of obesity, and the duration of surgery (Table 2). Table 3 presents the outcome of the two groups. Although there was no difference in the incidence of fever, the patients in group 3 had more serious infectious complications; their fever lasted longer, and they were hospitalized longer (P < 0.001). The incidence of wound infections in this group was also significantly

Table 2.

Significant

differences

between

groups

Group 1 + 2 Group 3 (n = 194) (n = 241) Obesity Duration

of surgery

19 (min) 41

Length of gestation, PROM, duration pelvic exams-all differences n.s.

Febrile morbidity.

34 63 of labor.

1 + 2 and 3. P

’ 0.004 0.000 number

of

Group

1+ 2 Group 3

(n=241)

(n = 194)

36 (14.9%) 38.48 2.58 4 I 4

26 ( 13.4%) 38.35 4.0 4 I 8

7 2 2 5 6.30 0

3

3 7.54 0

P

n.s. n.s. 0.001 “.S.

n.s. 0.1 I

0.008 n.s. ns. ns. 0.000

higher (P = 0.008). Among the 241 patients that received preoperative prophylaxis, 24 (9.95%) required additional antibiotics, compared to 24 (12.37%) of the 194 patients in group 3 (P = 0.06). Discussion

During the last 25 years, numerous studies addressed the issue of prophylactic antibiotics for cesarean section, involving thousands of patients, Different antibiotic regimens have been used in the early 1970s demonstrating a significant reduction in infectious morbidity section following emergency cesarean [6,12,14]. However, several concerns have been expressed: (1) The exposure of the baby to the antibiotics. (2) These antibiotics effects on the ability to take cultures from the baby. (3) The development of resistant organisms. Since Gordon et al. [7] have demonstrated the effectiveness of the prophylactic antibiotics, even when the first dose was given after the umbilical cord had been clamped, most centers adopted this routine. Also, a shift from multiple doses to a single dose of cefoxitine occurred following Hawrylyshyn’s report in 1983 [8]. There may be an over-concern regarding intrauterine exposure of the fetus to the antiArricle

260

Fejgin et al.

biotics. Two recent studies evaluating transplacental transfer of ceftriaxone and cefuroxime, demonstrated only minimal fetal tissue and serum levels within 1 h of maternal administration 19,lo]. The newer extended-spectrum antibiotics were expected to be superior, since most postoperative infections are caused by multiple aerobic and anaerobic pathogens. However, an attempt to achieve further reduction in the post cesarean section febrile morbidity, by the use of those extended-spectrum cephalosporins, failed. Carlson and Duff [1] demonstrated no significant difference in the infectious morbidity, when they compared a single dose of cefazoline to a single dose of cefotetan, both given after cord-clamping. Other researchers came to the same conclusions [3,5]. In the first part of our study, we compared extended-spectrum cephalosporins, two which were given before the incision was made. Both were equally effective in preventing serious infectious complications. Half of the patients who developed fever, did not retreatment. additional antibiotic quire Although the antibiotics were administered pre-operatively, we have encountered no illeffects in the newborns. In the second arm of our study, we demonstrated, that these more advanced cephalosporins were significantly more effective than the first generation one, in the prevention of wound infections, and in shortening the duration of fever and the length of hospitalization. The shorter procedure time may have contributed to the reduction in the incidence of wound infections in group 3. Principles of surgical prophylaxis have established that the maximum concentration of antibiotic should be present in the tissues when the incision is made [13]. In this aspect, cesarean section prophylaxis is unique. One may postulate that our favorable results in the extended-spectrum cephalosporins group may be related to the fact that we have used these advanced cephalosporins as ‘true prophylaxis’. By achieving tissue levels Int J

Gynecol

Obstet 43

prior to time of incision, the patients may have benefited from the wider spectrum of coverage of these antibiotics. This may explain why other studies, in which these advanced antibiotics were administered intraoperatively, failed to show any advantage when used as prophylaxis. In order to confirm our observation, two additional studies are required: one, in which both cefamezine and an extended-spectrum cephalosporin will be given pre-operatively, and a second one, in which the same extended cephalosporin is randomized to pre- and intra-operative administration. References I

2

3

4

5 6

1

8

Carlson C, Duff P: Antibiotic prophylaxis for cesarean delivery: Is an extended-spectrum agent necessary? Obstet Gynecol 76: 343, 1990. Cormier P, Leng JJ, Janky E, Duthil B, Brouste V: Prevention of infectious complications after cesarean section by the use of cefotetan. J Gynecol Obstet Biol Reprod 18: 388, 1989. Duff P, Robertson AW, Read JA: Single-dose cefazolin versus cefonicid for antibiotic prophylaxis in cesarean delivery. Obstet Gynecol 70: 718, 1987. Galask RP, Weiner C, Petzold CR: Comparison of single dose cefmetazole and cefotetan prophylaxis in women undergoing primary cesarean section. J Antimicrob Chemother 23(Suppl.): 105, 1989. Galask RP: Changing concepts in obstetric antibiotic prophylaxis. Am J Obstet Gynecol 157: 491, 1987. Gibbs RS, Hunt JE, Schwarz RH: A follow-up study on prophylactic antibiotics in cesarean section. Am J Obstet Gynecol 117: 419, 1973. Gordon HR, Phelps D, Blanchard K: Prophylactic Cesarean Section antibiotics: maternal and neonatal morbidity. Obstet Gynecol 53: 151, 1979. Hawrylyshyn PA, Bernstein P, Papsin FR: Short-term antibiotic prophylaxis in high-risk patients following cesarean section. Am J Obstet Gynecol 156: 285, 1983. Holt DE, Fisk NM, Spencer JAD, deLouvois J. Hurley R, Harvey D: Transplacental transfer of cefuroxime in uncomplicated pregnancies and those complicated by hydrops or changes in amniotic fluid volume. Arch Dis Child 68: 54, 1993. Lang R. Shalit I, Segal J. Arbel Y, Markov S, Hass H, Fejgin M. Maternal and fetal serum and tissue level of ceftriaxone following preoperative prophylaxis in emergency cesarean section. Chemotherapy 39: 77, 1993. Mancuso S, Oliva GC: A long-acting cephalosporin in short-term prophylaxis in obstetrics and gynecology. Eur Surg Res 21(Suppl.): 19, 1989.

Antibiotics for cesarean section 12

Morrison JC, Coxwell WL, Kennedy BS et al: The use of prophylactic antibiotics in patients undergoing cesarean section. Surg Gynecol Obstet 136: 425, 1973. 13 Smaill F: Antibiotic prophylaxis and caesarean section. Br J Obstet Gynaecol 99: 789. 1992. I4 Weissberg SM, Edwards NL. O’Leary JA: Prophylactic antibiotics in cesarean section. Obstet Gynecol 38: 290, 1971.

261

Address for reprints:

M.D. Fejgin Department of Obstetrics and Gyaecology Meir Hospital Kfar-Saba 44281 Israel

Article