Abstract:

Background: Caesarean section is a commonly performed operation worldwide. It was been found to increase rates of maternal infectious morbidities more than five times when compared to vaginal delivery. Provision of intravenous prophylactic antibiotics 30-60 minutes prior to caesarean section has been found to reduce post-caesarean infection tremendously. Many centres recommend provision of a single dose of antibiotics, as repeated doses offer no benefit over a single dose. At Bugando Medical Centre, post caesarean infection is among the top five causes of admission at post-natal ward. Unfortunately, there is no consistent protocol for the administration of antibiotic prophylaxis to patients who are designated for caesarean section. Common practice and generally the clinician’s preference are to provide repeated dosages of antibiotic prophylaxis after caesarean section to most of the patients. This study aimed to determine the comparative efficacy of single dose of gentamicin in combination with metronidazole versus multiple doses for prevention of post caesarean infection.

Methods: The study was open-label, randomized, clinical trial conducted at Bugando Medical Centre, Mwanza, Tanzania for a duration of 7 months. A total of 500 eligible candidates were enrolled in the study. Study subjects were randomly allocated into two study arms; “A” and “B”. Candidates in “A” received a single dose of gentamicin in combination with metronidazole 30-60 minutes prior to the operation and candidates in “B” received the same drugs prior to the operation and continue with gentamicin and metronidazole for 24 hours. The two groups were followed up for a period of one month and assessed for signs and symptoms for surgical site infection.

Results: recruited 500 pregnant women who were about to undergo caesarean section. A total of 281 women (56.2%) had age between 21-30 years and 340 (68%) were multigravida. A total of 287 (57.4%) of those who underwent emergency caesarean section had ruptures amniotic membrane either spontaneously or artificially. Most of these women had BMI of 25kg/m2 and above. They were randomly allocated to either study arm A or B. The cumulative incidence among the participants who used single dose (study arm A) was 4.8% [95% CI 2.2-7.4] compared to 6.4% [95% CI 3.4-9.4] for the clients used multiple doses (study arm B). The difference was not statistically significant (p-value =0.2183).

Conclusion: In our setting, the administration of intravenous single dose of gentamicin (3mg/kg) in combination with 500 mg of metronidazole before emergency caesarean section for prevention of infection is statistically equivalent to multiple doses of the same regimen given with 24 hrs. Therefore we recommend to administration of pre-operative single dose antibiotic prophylaxis for emergency caesarean.

Trial Registration: Current Controlled Trials ISRCTN4462542