Single Versus Multiple Doses Antibiotic Prophylaxis for Elective Caesarean Section at the Korle Bu Teaching Hospital

doi:10.21203/rs.3.rs-1396754/v1

Objective To compare the effectiveness of single dose to multiple doses antibiotic prophylaxis for elective caesarean section in Korle-Bu Teaching Hospital.

Design Randomized non-inferiority comparative study

Setting and population Eighty-six (86) pregnant women admitted for elective caesarean section and treated with single dose antibiotic and 86 pregnant women admitted for elective caesarean section and treated with multiple doses antibiotic in Korle-Bu Teaching Hospital, Ghana.

Methods This study was randomized into two groups. Group A were given single dose of Amoxicillin-clavulanate potassium and metronidazole while group B were given multiple doses. The patients were examined on postoperative day 3, 14, 42 for signs of wound infection and endometritis. Statistical analysis was done using the student t-test and the chi-square test. Results were presented in cumulative incidence and as odds ratio together with 95% confidence intervals and P-value.

Main outcome Effectiveness of single dose to multiple doses antibiotic prophylaxis for elective caesarean section

Results: The SSI over the study period was 9.4%. All infections were superficial incisional SSI. Six (7.1%) and 10(11.6%) of the patients in the single dose and multiple dose arm respectively had wound infection. A statistically non-significant difference of 4.5% (difference 4.5: 95% CI -13.1- 4.1) (p = 0.305) was observed.

Conclusions These results suggest that a single prophylactic intravenous dose of Amoxicillin-clavulanic acid 1.2g and Metronidazole (500mg) given before caesarean section is non-inferior to a multiple dose regimen with regards to post caesarean section SSI.

Antibiotic prophylaxis

elective caesarean section

surgical site infection

Caesarean section (C/S) has classically been defined as delivery of a fetus beyond the period of viability through a surgical incision on the anterior uterine wall. It is the most common major operation performed on women worldwide.⁽¹⁾ The rates of C/S vary widely by country, healthcare facility and delivering physician, partly because of differing perceptions by healthcare providers as well as by pregnant women of its benefits and risks. The World Health Organization recommends a C/S rate of 10–15%.⁽²⁾ In Ghana, the national C/S rate is 6.9% whilst in developed countries like the US and Italy they are respectively 30.2% and 37.4%.⁽³⁾ The relative safety of caesarean delivery and its perceived advantages relative to vaginal delivery have resulted in a change in the perceived risk–benefit ratio, which has accelerated acceptance. Indeed, a belief has become widespread that the risks of caesarean delivery for healthy women are so low as to make it a reasonable elective option for childbirth.⁽⁴⁾

Caesarean delivery is, however, a risk factor for postpartum infections. Women who undergo caesarean section have a 5 to 20 fold greater risk of postpartum infection than women having vaginal deliveries. The incidence of post-caesarean infection varies widely worldwide – ranging from 2.5–20.5%.⁽⁵⁾ Prophylactic antibiotics are always indicated when a caesarean delivery follows labor or with previously ruptured membranes. In recent years, this treatment has been extended to all cases, both elective and emergency C/S.⁽⁶⁾ Antibiotic prophylaxis refers to administration of antibiotics to prevent infection. It is distinguished from antibiotic treatment by (i) short courses(up to 24 hours), frequently a single dose; and (ii) administration shortly before or at the time of possible bacterial inoculation.⁽⁷⁾

The frequency of post caesarean endomyometritis with the use of appropriate prophylactic antibiotics is usually less than 5%, much reduced from pre antibiotic times. Prolonged labor, prolonged rupture of membranes, and lower socioeconomic status appear to be the factors that most influence the rate of this complication.⁽⁸⁾ The recommended duration of prophylactic antibiotics has gradually reduced from 5days to 72hours, to 24hours (three doses) and finally to a single dose.⁽⁹⁾ Administration of antibiotic prophylaxis within an hour prior to skin incision is more effective in reducing post-caesarean infectious morbidity when compared to administration of the same drugs after cord clamping and has no effect on neonatal infection.⁽¹⁰⁾

At the Korle Bu Teaching Hospital (KBTH), the rate of caesarean delivery is estimated to be 39% and that of elective C/S is 12%. Wound infection and endometritis following C/S is about 5.8% and 1.2% respectively.⁽¹³⁾ The predominant practice is to provide repeated doses of prophylactic antibiotics for at least 5 days after C/S. Amoxicillin-clavulanate potassium (amoksiclav) and metronidazole are the common antibiotics that are used as prophylaxis for infection during caesarean delivery. However, there is lack of consensus on the duration of prophylactic antibiotics for elective C/S in KBTH. It is hypothesized that there is no statistically significant difference in effectiveness between single dose and multiple doses antibiotic as prophylaxis against SSI in elective C/S.

Study population

The study population was all pregnant women who were admitted to the obstetric unit and scheduled for elective C/S, and consented for the study. However, all pregnant women with fever (temperature of 38°C and above), in labour, allergic to Amoksiclav and/or metronidazole, had Sickle cell disease or had used antibiotics in the 24 hours preceding the operation, were HIV positive, had premature rupture of membranes and became ill within 48–72 hours postoperatively were not eligible.

The sample size was calculated using the standard formula comparing two proportions:

Sample size =

(Zα + Z_β)^{2 χ} 2 [( p₁ + p₂/2)(1- (p₁ + p₂)/2)]/ (p₁-p₂)²

P₁ = proportion of post elective C/S women who were given single dose prophylactic antibiotics and had SSI;

P₂ = proportion of post elective C/S women who were given multiple doses prophylactic antibiotics and developed SSI.

The proportion of post elective C/S for women who had single and multiple doses of prophylactic antibiotics and developed deep wound infection were 1% and 2% respectively.⁽¹⁴⁾

At 95% confidence level and power of 80%, Z_α=1.96 and Z_β=0.84 and using the proportions P₁ and P₂, a total minimum sample of 158 is obtained.

However, for this noninferiority trial, to indicate noninferiority, a 10% difference in effectiveness between the two study arms as maximum acceptable value was selected. A two-sided test of equivalence with a significance level of 0.05 was used. The final sample was 172 (86 women treated with single dose antibiotic and 86 women treated with multiple doses antibiotic).

Sampling procedure

Randomization

Eligible candidates were allocated into two study arms: A and B. Each study arm had a total of 86 participants. Study arm A were those who received a single intravenous dose of Amoksiclav 1.2g and metronidazole 500 mg 30 to 60 minutes before operation. Study arm B were those who received multiple doses of intravenous Amoksiclav 1.2g and metronidazole 500 mg 30 to 60 minutes before operation, intravenous Amoksiclav 1.2g after 12h and metronidazole 500 mg every 8h for 24h and then oral Amoksiclav 625mg 12 hourly and metronidazole 400mg every 8h for 5 days.

Selection of the study participants was done by trained research assistants. They were put into two blocks; block 1 and block 2. Block 1 were participants who have had previous abdominal surgical scars and block 2 were those who have not had any previous abdominal surgical scars. Each block contained 86 participants. Simple randomization was used in each block to allocate study participants into study arm A and B. Then, 172 opaque envelopes of the same size and colour were prepared. Each envelope contained paper marked “study arm A” or “study arm B”. These envelopes were put into two boxes. Then the envelopes in each box were mixed thoroughly before selection of an envelope was done. Box 1 was used to randomize participants in block 1. Each participant selected one sealed envelope and the study arm to which she belonged was ascertained by the research assistant. All subsequent participants were randomized in like manner.

Primary outcome measures

SSI was the primary outcome - the assessment for any evidence of SSI was done 72 hours after C/S, as well as on post discharge follow-up days (Day 14 and Day 42 post-C/S). The presence of fever (febrile morbidity), signs and symptoms of abdominal wound infection or endometritis indicated SSI. Febrile morbidity was defined by temperature of 38°C or more at least 4 hours apart on two or more occasions, excluding the first 24 hours after delivery.⁽⁷⁴⁾ Abdominal wound infection was defined by partial or total dehiscence or presence of purulent or serous discharge from the wound with indurations, warmth and tenderness.

Endometritis was defined by the presence of fever (38°C or more) in association with one or more of the following: uterine tenderness or foul smelling lochia. In both groups, the bladder catheter was removed after 24 hours provided there was no complication during surgery. Wound care followed the standard scheme in both groups, the occlusive dressing applied in the theatre being removed after 72 hours.

The patient was discharged on Day 3 if there was no sign of infection or complication and asked to return on Day 14 to the postnatal clinic for general assessment and assessment of the wound. Then, the patient returned on Day 42 (and on her team doctors on call duty day) post-caesarean section for reassessment. On Day 14 and Day 42, axillary temperature was measured, and the abdomen and wound were examined for signs of infection. All patients who developed complications were promptly attended to and appropriately treated. All study participants were given time based appointment to reduce waiting time for them.

Statistical analysis

Data was entered into SPSS version 16.0 (University of Chicago, Chicago, USA) for cleaning and analysis. Study outcomes were assessed by intention - to - treat analysis. Analysis involved baseline and hypothesis testing. Baseline analysis involved comparing of the baseline characteristics between the two study arms. Results for continuous variables was expressed as means with standard deviation and categorical variables as absolute numbers with percentages between parentheses. Means were compared using a Student’s t-test (normal distribution). Chi-square test was used to compare the proportions. Results was presented in cumulative incidence and as an odds ratio together with 95% confidence intervals. Sub-group analysis was performed to determine the association between SSI and other covariates such as duration of the surgery. Covariates with P-value less than 0.05 was considered significant.

Background characteristics

From 20th January to 5th May 2016, 172 women who were admitted for elective C/S at the KBTH participated in the study. One (1) participant in the single dose arm was lost to follow up. The results of the remaining 171 patients are presented (Fig. 1).

Socio-demographic characteristics of the patients

The ages of the participants ranged from 16 to 45years with a mean age of 32.6 ± (SD = 5.2) years in the single dose arm and 31.5± (SD = 5.1) years in the multiple dose arm. Most of the patients, 149 (88%), have attained at least secondary education. There was no statistically significant difference in the sociodemographic characteristics between the patients in the two study arms. (Table 1).

Obstetric and other clinical characteristics of the patients

Most 125(73%) of the patients, 62(72.9%) in the single dose arm and 63(73.3%) in the multiple dose arm were multigravidas. The mean gestational ages at which the patients presented for the surgery in both study arms was approximately 38weeks. However, these obstetric characteristics did not show statistically significant difference between the study arms. (Table 2). Other clinical characteristics, including the preoperative hemoglobin level, and other comorbidities like hypertension showed no statistical significant difference between the study arms. (Table 2).

Characteristics associated with the surgeries and the three days postoperative period

About half (86) of the patients were operated on by senior resident doctors (Table 3). During the surgery, 97.1% of the patients were given spinal anesthesia. Majority (71.3%) of the patients lost less than 500mls of blood intraoperatively. (Table 3).

The duration of the surgery was more than 60minutes in both study arms. During the first 3 days of the postoperative period, (77.6%) in the single dose arm and 76(88.4%) in the multiple dose arm had low hemoglobin level (Hb < 11g/dl). There was no statistically significant difference in the characteristics associated with the surgeries and the 3days postoperative period in the study arms. (Table 3).

Outcome of the surgical site post caesarean section

Clinical indicators of infection

No mother developed fever (> 38⁰c) during the postoperative period whilst on admission. Fever was recorded in two (2) of the patients, one in each study arm and this was noticed during the two (2) weeks postnatal visit. The difference in the incidence of SSI between the study arms was not statistically significant. (Table 4 and Fig. 2).

Period of Occurrence of SSI

Most (93.75%) of the SSI were detected during the second week and the sixth week postnatal visit. One patient (6.25%) developed SSI during the first week postoperative period and this occurred while she was on the ward. (Fig. 3).

Culture isolates of the caesarean wound

Out of a total of 16 cases (9.36%) of wound infection diagnosed during the study period, twelve (80%) yielded micro-organisms such as Staphylococcus aureus (53.33%). (Figs. 4, 5 and 6).

Antibiotic sensitivity of microbial isolates in caesarean wound infection

Of the 9 Staphylococcus aureus isolated, 4(44.4%) were sensitive to Cloxacillin; 2(22.2%) were sensitive to Erythromycin and 1(11.1%) to Amoksiclav. (Table 5).

Distribution of SSI among Covariates in the Study Arms

About 68.8% of the patients who developed SSI had their surgery performed by senior residents. SSI was recorded in 68.8% of the patients whose duration of surgery was over 60minutes. Out of the 13 patients who had comorbidities, 23.1% developed SSI. (Table 6). Patients who were given the single dose regimen had lower incidence of SSI (7.1%). An absolute proportion difference of 4.5% (difference 4.5: 95% CI -13.1- 4.1) (p = 0.305) was observed. (Table 6). There is no statistically significant association between the covariates and SSI. (Table 7).

Main findings

The effectiveness of single dose verses multiple doses antibiotic prophylaxis for elective C/S in KBTH was assessed. The study shows that administration of preoperative single dose prophylaxis has lower incidence rate of SSI compared to the multiple doses though this was statistically not significant. According to the non-inferiority margin (10%), the study shows that a single dose of prophylactic antibiotics is not inferior to multiple doses in preventing SSI.

Strengths and limitations

The strength of this study is the study design, a randomized non inferiority comparative study. It also assessed the same type of antibiotic in a single and multiple dose regimen at elective C/S. In addition, the antibiotics used are the regular antibiotics that are used in the department for elective C/S.

This study has some limitations. The researcher and all those involved in the follow up of the patients were not blinded to the antibiotic regimen received by the patients. This could introduce information bias in any of the arms. Secondly, the study was carried out in a tertiary hospital and therefore the results may not be extrapolated to lower levels of facility. Again, with several doctors assessing and diagnosing SSI, it is possible to have inter-observer variation in diagnosis. However, with the strict criteria applied for the diagnosis, this is not expected to have affected the results even if it occurred. Also, the study did not assess whether clients over the study period used antibiotics for any other reason; that could be confounding. It did not also assess wound care after discharge.

Interpretation

Though SSI are not life threatening in most cases, they tend to prolong the length of hospital stay, increase hospital cost and in some cases, re-admission for women trying to cope with both the postoperative period and new baby.⁽²⁷⁾ The global estimate of SSI is 0.5–15%.⁽²²⁾ In the current study, the SSI over the study period was 9.4%. About 7.1% and 11.6% of the patients in the single dose and multiple dose arm respectively had wound infection. Though these are within the global estimate, they are higher than the rate, 5.8% found by Aduama et al at the same study site.⁽¹³⁾ The SSI rate in this current study is however lower than the rate of 15.4% found in the study at the Komfo Anokye Teaching Hospital, Kumasi, Ghana by Danso and Sarkodie.⁽⁵⁶⁾

Previous studies have reported that there is no added benefit of using multiple doses over single dose antibiotic as prophylasix for SSI.^(11,14,69)A similar non inferiority trial comparing a single prophylactic dose of Ampicillin combined with Metronidazole with multiple (5-day) regimen of the same drug in a low resource setting did not find any significant difference between the two regimen.⁽¹¹⁾ Studies have also shown that multiple doses regimen is associated with higher medication cost than single dose.⁽⁷¹⁾ The use of single dose regimen will reduce cost without increasing the risk of SSI. It will also reduce workload to the nurses especially at night when fewer nurses are on duty on the ward.

Pathogens that cause SSI are acquired either endogenously from the patients own flora or exogenously from contact with operative room personnel or the environment. In Dhar et al’s study on post caesarean section wound infections, the most common organism responsible for SSI were Staphylococcus aureus (31%) followed by the gram negative Escherichia coli group (19%). Polymicrobial infection was noted in 20% while 22% yielded no growth. This was probably due to the use of broad spectrum antibiotics prior to the wound swab. The main organisms found to be growing together were: Klebsiella and E. coli; Klebsiella and Proteus; Klebsiella and S. aureus; E. coli and coagulase- negative staphylococcus and E. coli and Proteus.⁽²²⁾ In the Danso and Adu-Sarkodie study, of the 53 wound infections recorded, microorganisms were isolated from 48(90%).

About 7.6% of patients who undergo C/S develop infection within 30days during the puerperium. Up to 80% of these infections occur after discharge from hospital. Only about 1.8% occur before hospital discharge. ⁽³²⁾ Another study had shown that SSI occurred between the 3rd and 22nd day postoperatively with a median time of occurrence of 7days post operation.⁽⁴⁶⁾ This current study is consistent with the above findings: One of the patients (6%) was noted to have developed SSI by the 3rd day post operatively and the rest (94%) on the 2nd and 6th week post operatively.

The experience of surgeons performing the C/S is a critical determinant of SSI. In a study on the incidence of post C/S by Mpogoro et al, it was shown that operations performed by an intern or junior surgeon increased the risk for SSI by 4 folds.⁽⁴⁶⁾ In the current study, however, SSI incidence among patients operated on by senior resident doctors was found to be higher (70%) than that of junior resident doctors (30%). This finding may be due to the fact that senior resident doctors did a larger number 86(50%) of the elective C/S than the junior resident doctors 68(40%). It could also be due to complacency on the parts of senior resident doctors in observing the basic tenets of surgery. The current study also showed that the incidence of SSI is higher 11(70%) with prolonged duration of surgery (> 60minutes) and this is consistent with findings from previous studies.^(47,48) This study showed that patients who had spinal anaesthesia had higher incidence of SSI 15(93.8%) than those who had general anaesthesia 1(6.2%) and patients who had low transverse skin incision (pfannenstiel) had higher incidence of SSI 14(87.5%) than those who had midline skin incision 2(12.5%). This is not consistent with findings from previous studies.^(41,42,45) This is because a very small proportion of the patients had general anaesthesia (3%) and midline incision (4%).

A single prophylactic intravenous dose of Amoxicillin-clavulanic acid (Amoksiclav) 1.2g and Metronidazole (500mg) given before C/S is non-inferior to a multiple doses regimen with regards to post C/S SSI. There is the need for a change in the practice of the multiple dose regimen as antibiotic prophylaxis for elective C/S in the KBTH. Hence, a hospital protocol with emphasis on single dose of antibiotic prophylasix in elective C/S needs to be developed in non-tertiary facilities to ascertain the applicability of the single dose regimen. Such endeavors will inform policy on antibiotic prophylaxis during elective C/S. The findings of this study could also have cost implication for both the institution and patients as the single dose regimen will be cheaper than the multiple dose.

Ethics approval and consent to participate

All methods of the study were carried out in accordance with Declaration of Hesinkin and Data Protection Regulation of Ghana, thus, Data Protection Act 2012 (Act 843). There was Institution approval from Korle-Bu Teaching Hospital (KBTH-STC/IRB/009/2015), scientific and technical committee approval (KBTH-STC 009/2015) and College of Health Sciences Ethical and Protocol Review Committee (CHS-Et/M.4 – P3.5/2015 - 2016). Written consent form was read and signed by participants before participation in the study

Consent for publication

Not applicable

Availability of data materials

The datasets generated and/or analyzed during the current study are not publicly available due to the lack of consent from all participants to share raw data but are available from the corresponding author on reason request.

Competing interest

No declared

Funding

Fully funded the principal investigator

Author’s contribution and acknowledgments

FP was responsible for the conception, design, participants’ recruitment and collection of present study. FP was involved in the data analysis. FP drafted the article. FP gave approval of the final version for publication.

I acknowledge senior and junior resident doctors at KBTH, and all pregnant mothers who consented to participate in the study.

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Table 1: Sociodemographic Characteristic of The Patients in the two study arms, n=171

Characteristics	Single dose (n=85) f (%)	Multiple doses (n=86) f (%)	Statistical test P-value
Mean Age in years, M(SD)	32.6 (± 5.2)	31.5( ± 5.1)	t(169) =1.422 p=0.157
Age group			χ2(5)=7.124, p=0.196^b
16-20	3(3.5)	2(2.3)
21-25	2(2.4)	10(11.6)
26-30	25(29.4)	26(30.2)
31-35	27(31.8)	28(32.6)
36-40	26(30.6)	19(22.1)
41-45	2(2.4)	1(1.2)
Level of Education			χ2(3)=1.778, p=0.620
No formal education	3(3.5)	7(8.1)
Primary	6(7.1)	6(7.0)
Secondary	50(58.8)	50(58.1)
Tertiary	26(30.6)	23(26.7)
Occupation			χ2(5)=4.336 p=0.502
Unemployed	10(11.8)	7(8.1)
Petty Traders	44(51.8)	48(55.8)
Business women	16(18.8)	12(14.0)
Administrators	8(9.4)	7(8.1)
Professionals	7(8.2)	12(14.0)

Note: Statistical test compares Participants in each study arm for each variable

f = frequency t=student t test performed M= mean SD=standard deviation b=Fisher Exact test

Table 2: Obstetric and Other Clinical Characteristics of The Patients, n=171

Characteristic	Single dose(n=85) f (%)	Multiple doses(n=86) f (%)	Statistical test P-value
Gravidity			χ2(1)=0.002 p=0.963
Primigravida	23(27.1)	23(26.7)
Multigravida	62(72.9)	63(73.3)
Mean Parity(M,SD)	1.38(± 1.18)	1.52(± 1.40)	t(169)=-0.741 p=0.460
Mean Gestational age in weeks(M,SD)	38.1(± 5.2)	38.2(± 5.6)	t(169)=-0.262 p=0.097
Preoperative Hemoglobin level in g/dl			χ2(1)=0.489 p=0.484
Less than 11g/dl	36(42.4)	41(47.7)
11g/dl or more	49(57.6)	45(52.3)
Other comorbidity			χ2(3)=3.137 p=0.371^b
Hypertension	3(3.5)	4(4.7)
Diabetes	3(3.5)	1(1.2)
Hypertensive and diabetes	0(0)	2(2.3)
No Comorbidity	79(92.9)	79(91.9)
Indication for C/S			χ2(6)=2.299 p=0.890
Elderly primigravida	7(8.2)	6(7.0)
1 previous c/s	26(30.6)	24(27.9)
Placenta Previa	15(17.6)	18(20.9)
2 or more previous c/s	15(17.6)	16(18.6)
Bad obstetric history	10(11.8)	11(12.8)
Breech presentation	9(10.6)	6(7.0)
*Others	3(3.5)	5(5.8)

*Previous extensive myomectomy, prolonged fertility treatment, transverse lie

Table 3: Characteristics Associated with Surgeries and the three days postoperative period, n = 171

Characteristics	Single dose(n=85)	Multiple doses(n=86)	Statistical test P- value
Cadre of Surgeons			χ2(2)=1.100 p=0.577
Resident	31(36.5)	37(43.0)
Senior Resident	44(51.8)	42(48.8)
Consultant	10(11.8)	7(8.9)
Anaesthesia			χ2(1)=0.218 p=0.640^b
General	3(3.5)	2(2.3)
Spinal	82(96.5)	84(97.7)
Skin incision			χ2(1)=0.000 p=1.000^b
Pfannenstiel	82(96.5)	83(96.5)
Midline	3(3.5)	3(3.5)
Blood loss			χ2(2)=1.398 p=0.554^b
Less than 500ml	59(69.4)	63(73.3)
500ml-1000ml	26(30.6)	22(25.6)
More than 1000ml	0(0)	1(1.2)
Duration of surgery			χ2(3)=1.823 p=0.671^b
less than 30min	3(3.5)	2(2.3)
30min-60min	28(32.9)	28(25.6)
61min-120min	48(56.5)	53(61.6)
More than 120min	6(7.1)	9(10.5)
Post op Hb			χ2(1)=3.492 p=0.062
less than 11g/dl	66(77.6)	76(88.4)
11g/dl or more	19(22.40	10(11.6)

Mean duration of hospital stay post-surgery(M,SD)	3.02(± 0.15)	3.22(± 1.29)	t(169)=-1.404 p=0.162

Table 4.4: Clinical Indicators of Infection, n =171

Indicator	Single dose (n=85) f(%)	Multiple dose (n=86) f(%)	OR 95% CI	Statistical test P value
Fever(>38⁰c)	1(1.18)	1(1.16)	0.988(0.061-16.060)	X²(1)=0.000, p=1.000^b
Wound infection	6(7.10)	10(11.62)	1.732(0.600-5.000)	X²(1)=1.052, p=0.305
Uterine tenderness	0(0)	0(0)
Lochia smell
Foul	0(0)	0(0)

Table 5: Antibiotic Sensitivity of Microbial Isolates in Caesarean Wound Infection

Microbial isolate	Antibiotic	Sensitivity (%)
S. Aureus		N=9
	Amokxiclav	1(11.1)
	Cloxacillin	4(44.4)
	Gentamicin	1(11.1)
	Erythromycin	2(22.2)
E coli		N=2
	Gentamicin	1(50)
	Cefuroxime	1(50)
P aeruginosa		N=1
	Gentamicin	1(100)
Providentia		N=1
	Cefuroxime	1(100)
	Ciprofloxacin	1(100)
	Cotrimoxazol	1(100)
	Gentamicin	1(100)
Citrobacter		N=1
	Cefuroxime	1(100)
	Gentamicin	1(100)

Table 6: Distribution of SSI among Covariates In The Study Arms, n =16

Covariates	Single dose f(%)	Multiple doses f(%)	Statistical test P value
Age in years			χ2(1)=1.067 p=0.302^b
21-30	2(33.3)	6(60.0)
31-40	4(66.7)	4(40.0)
Occupation			χ2(3)=2.655 p=0.497^b
Unemployed	2(33.3)	2(20.0)
Petty traders	4(66.7)	4(40.0)
Business women	0(0)	2(20.0)
Administrators	0(0)	2(20.0)
Education			χ2(2)=1.147 p=0.753^b
Primary	0(0)	1(10.0)
Secondary	5(83.3)	6(60.0)
Tertiary	1(16.7)	3(30.0)
Preoperative Hemoglobin in g/dl			χ2(1)=2.861 p=0.145^b
Less than 11g/dl	1(16.7)	6(60.0)
11g/dl or more	5(83.3)	4(40.0)
Other co morbidity			χ2(2)=2.872 p=0.238
No co morbidity	5(83.3)	8(80.0)
Diabetes in Pregnancy	0(0.0)	2(20.0)
Hypertension in pregnancy	1(16.7)	0(0.0)
Surgeon			χ2(1)=4.364 p=0.058^b
Resident	0(0.0)	5(50.0)
Senior resident	6(100.0)	5(50.0)
Anaesthesia			χ2(1)=0.640 p=1.000^b
Spinal	6(100.0)	9(90.0)
GA	0(0.0)	1(10.0)
Covariates	Single dose f(%)	Multiple doses f(%)	Statistical test P value
Incision			χ2(1)=1.371 p=0.500^b
Pfannenstiel	6(100.0)	8(80.0)
Midline	0(0.0)	2(20.0)
Skin Suture material			χ2(2)=1.315 p=0.610^b
Vicryl 0	2(33.3)	2(20.0)
Vicryl 2-0	4(67.7)	6(60.0)
Nylon 0	0(0.0)	2(20.0)
Intra operative Blood loss			χ2(2)=1.147 p=0.753^b
Less than 500ml	5(83.3)	6(60.0)
500ml-1000ml	1(16.7)	3(30.0)
>1000ml	0(0.0)	1(10.0)
Duration of surgery			χ2(3)=4.175 p=0.315^b
Less than 30min	1(16.7)	0(0.0)
30min -60min	2(33.3)	2(20.0)
61min-120min	3(50.0)	4(40.0)
>120min	0(0.0)	4(40.0)
Post -operative Hemoglobin in g/dl			χ2(1)=0.152 p=0.696^b
Less than 11g/dl	5(83.3)	9(90.0)
11g/dl or more	1(16.7)	1(10.0)

Table 7: Association between the Covariates and Surgical site infection

Covariates	SSI f(%)	No SSI f(%)	Statistical test P value
Age in years			χ2(3)=1.069 p=0.905^b
Less than 21	0(0)	5(3.2)
21-30	7(43.8)	56(36.1)
31-40	8(56.2)	92(58.7)
41-50	0(0)	3(1.9)
Education			χ2(3)=1.448 p=0.684^b
No formal education	0(0)	10(6.5)
Primary	1(6.2)	11(7.1)
Secondary	11(68.8)	89(57.4)
Tertiary	4(25.0)	45(29.0)
Occupation			χ2(4)=6.476 p=0.166^b
Unemployed	4(25.0)	13(8.4)
Petty trader	8(50.0)	84(54.2)
Business woman	2(12.5)	26(16.8)
Administrator	2(12.5)	13(8.4)
Professional	0(0)	19(12.3)
Preoperative hemoglobin in g/dl			χ2(1)=0.176 p=0.737^b
Less than 11	8(50.0)	69(44.5)
11 or more	8(50.0)	86(55.5)
Diabetes			χ2(1)=3.177 p=0.131^b
No diabetes	14(87.5)	150(96.8)
Diabetes	2(12.5)	5(3.2)
Hypertension			χ2(1)=1.182 p=0.327^b
No hypertension	15(93.8)	152(98.1)
Hypertension	1(6.2)	3(1.9)
Hypertension and diabetes			χ2(1)=0.209 p=1.000^b
No hypertension and diabetes	16(100)	153(98.7)
Hypertension and diabetes	0(0)	2(1.3)
Cadre of surgeons			χ2(2)=3.272 p=0.195
Resident	5(31.2)	63(40.6)
Senior resident	11(68.8)	75(48.4)
Consultant	0(0)	17(11.0)
Type of anaesthesia			χ2(1)=0.688 p=0.392^b
Spinal	15(93.8)	151(97.4)
General	1(6.2)	4(2.6)
Skin incision			χ2(1)=4.215 p=0.099^b
Pfannenstiel	14(87.5)	151(97.4)
Midline	2(12.5)	4(2.6)
Intraoperative bloss			χ2(2)=5.355 p=0.109^b
Less than 500ml	11(68.8)	111(71.6)
500-1000ml	4(25.0)	44(28.4)
More than 1000ml	1(6.2)	0(0)
Skin suture used			χ2(2)=2.361 p=0.289
Vicryl-0	4(25.0)	59(38.1)
Vicryl 2-0	10(62.5)	88(56.5)
Nylon 0	2(12.5)	8(5.2)
Duration of surgery			χ2(3)=6.440 p=0.063^b
Less than 30mins	1(6.2)	4(2.6)
30-60mins	4(25.0)	45(29.7)
61-120min	7(43.8)	94(60.6)
More than 120min	4(25.0)	11(7.1)
Postoperative hemoglobin			χ2(1)=0.040 p=0.737^b
Less than 11	13(81.2)	129(83.2)
11 or more	2(18.8)	26(16.8)

No competing interests reported.

Supplementalmaterials.docx

Single Versus Multiple Doses Antibiotic Prophylaxis for Elective Caesarean Section at the Korle Bu Teaching Hospital

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Abstract

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Introduction

Methods