Comparison between Administration of Antibiotics for Caesarean Section prior to Skin Incision Versus after Cord Clamping and the Effect on post-caesarean Section Infection Morbidity: A Randomized Controlled Trial

Abstract

Summary C aesarean delivery is the most commonly performed surgery in the United States, with nearly 1.2 million procedures in 2004 (National Institutes of health state 2007).Infectious morbidity, consisting primarily of endomyometritis and wound infection remains a leading cause of postoperative complication (Henderson et al., 1996). Estimates of post caesarean infection rates range from 7% to 20% depending on demographic and obstetric variables (Ramsey et al., 2005). Infection following caesarean delivery results in not only increased hospital stay but also increases the cost of care. For example diagnosing and treating a single case of endometritis is estimated to cost $815 (Chelmow et al., 2004). Prophylactic antibiotics can reduce the incidence of post caesarean infectious morbidity by as much as 75%. The risk reduction is observed in both planned and emergent caesareans (Chelmow et al., 2001). . The goal of perioperative prophylaxis is to attain therapeutic levels of antibiotic agents in the tissues at the time of microbial contamination. Most obstetrician use a single agent, commonly a cephalosporin, as the prophylactic antibiotic of choice. (Costantine et al., 2008) Neither the use of broad spectrum antimicrobials nor the administration of additional doses postoperatively has shown to be superior to a single dose cephalosporin regimn (Gall et al., 1987). There is lack of consensus regarding the timing of prophylaxis in caesarean deliveries. The usual obstetric practice has been to administer these antibiotics at cord clamping. Concern has focused on the possibility that unnecessary fetal exposure might mask fetal infections and increase the need for a sepsis workup in newborn infants and the selection of resistant strains, with potential adverse effects on the baby (Costantine et al., 2008) The aim of this study is to compare the timing of prophylaxis for caesarean delivery whether preoperatively or after cord clamping and its influence on postoperative infectious morbidity as wound infection, endometritis and urinary tract infection. There were 2 RCTs (Thigpen et al., 2005 and Sullivan et al., 2007), a meta-analysis (Constantine et al., 2008) and a prospective cohort study (Young et al., 2012) comparing the timing of antibiotic prophylaxis for caesarean delivery and its influence on postoperative infectious morbidity. Sullivan et al., 2007 was the only study that showed statistical significance with postoperative infectious morbidity being less frequent in those who received antibiotics prior to caesarean section than those receiving antibiotics after cord clamping. This is a prospective randomized double-blind placebo-control trial conducted at Ain Shams Maternity Hospital. The study included any female in the child bearing period of gestational age 38 weeks or older with viable fetus, BMI< 30 and undergoing elective caesarean delivery. Patients excluded were those with preoperative haemoglobin less than 10 those with prolonged rupture of membranes (more than 6 hours), any evidence of infection and those with existing co-morbidity as Diabetes or autoimmune disease. The study population included 470 patients that were divided into 2 groups, each containing 235 patients  Study Group: includes patients that received 1 gm vial of Zinol® 15-60 minutes before the caesarean section and the placebo after the cord clamping.  Control Group: includes patients that received the placebo 15-60 minutes before the caesarean section and 1 gm vial of Zinol® after the cord clamping. An informed consent was obtained from all participants, in the current study all caesarean sections were performed by surgeons who have at least two year experience and any scar of previous caesarean section has been removed. Postoperatively, maternal temperature is measured on 2 separate occasions 6 hours apart with exclusion of the first 12 hours following surgery. The wound is inspected 48 hours, 7 days and 30 days after caesarean section for signs of superficial or deep incisional surgical site infection. Observation for endometritis (uterine tenderness, purulent drainage from the uterus, abdominal pain, fever or organism cultured from fluid. Detection of urinary tract infection with suprapubic tenderness, fever or positive urine culture. Results of our study demonstrated that there was no statistical difference between the two groups as regards wound infection and endometritis but showed statistical significance in overall infectious morbidity being statistically less frequent in those who received antibiotic prophylaxis 15-60 minutes prior to caesarean section.