Routine antibiotic prophylaxis after normal vaginal birth for reducing maternal infectious morbidity

Mercedes Bonet; Erika Ota; Chioma E Chibueze; Olufemi T Oladapo

doi:10.1002/14651858.CD012137.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 1. Antibiotic prophylaxis versus no treatment/placebo, Outcome 1 Endometritis.

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Analysis 1.2

Comparison 1 1. Antibiotic prophylaxis versus no treatment/placebo, Outcome 2 Urinary tract infection.

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Analysis 1.3

Comparison 1 1. Antibiotic prophylaxis versus no treatment/placebo, Outcome 3 Wound infection (episiotomy dehiscence).

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Analysis 1.4

Comparison 1 1. Antibiotic prophylaxis versus no treatment/placebo, Outcome 4 Adverse effects of antibiotics (skin rash).

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Analysis 1.5

Comparison 1 1. Antibiotic prophylaxis versus no treatment/placebo, Outcome 5 Length of maternal hospital stay ‐ days.

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Study	Experimental	Control
Fernandez 1993	3600 USD	9000 USD

Analysis 1.6

Comparison 1 1. Antibiotic prophylaxis versus no treatment/placebo, Outcome 6 Cost of care (cost of antibiotic prophylaxis, prolonged hospitalisation and treatment of endometritis).

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Summary of findings for the main comparison. Routine antibiotic prophylaxis compared to no treatment or placebo for preventing infections in women who had normal vaginal births

Routine antibiotic prophylaxis compared to no treatment/placebo for preventing infections in women who had normal vaginal births
Patient or population: Women who had normal vaginal births Setting: Healthcare facilities in Brazil, France and the USA. Intervention: Routine antibiotic prophylaxis (amoxicillin/clavulanic, chloramphenicol, sulphamethoxypyridazine) Comparison: Placebo or no treatment
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with no treatment/placebo	Risk with routine antibiotic prophylaxis
Incidence of severe maternal infectious morbidity (including septicaemia, septic shock, laparotomy/hysterectomy for infection, maternal intensive care unit admission, or organ failure)	not estimable	not estimable	not estimable	0 (0 RCT)	‐	No trial reported this outcome
Endometritis	Study population		RR 0.28 (0.09 to 0.83)	1364 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1, 2}	‐
	23 per 1000	7 per 1000 (2 to 20)
Urinary tract infection	Study population		RR 0.25 (0.05 to 1.19)	1706 (2 RCTs)	⊕⊕⊝⊝ LOW ¹	‐
	32 per 1000	8 per 1000 (4 to 18)
Wound infection (episiotomy dehiscence)	Study population		RR 0.78 (0.31 to 1.96)	1364 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1, 5}	‐
	7 per 1000	10 per 1000 (3 to 32)
Adverse effects of antibiotics (skin rash)	Study population		RR 3.03 (0.32 to 28.95)	1706 (2 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1, 3}	‐
	0 per 1000	0 per 1000 (0 to 0)
Length of maternal hospital stay	The mean length of maternal hospital stay (including maternal re‐admission to hospital) was 5.12 days	MD 0.15 lower (0.31 lower to 0.01 higher)	not estimable	1291 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{4, 5}	‐
Individual antimicrobial resistance	not estimable	not estimable	not estimable	0 (0 RCT)	‐	No trial reported this outcome
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹Two studies with very serious design limitations (‐2). ²Few events (‐1). ³Few events, wide confidence interval crossing the line of no effect (‐1). ⁴One study with very serious design limitations (‐2). ⁵Wide confidence interval crossing the line of no effect (‐1).

Summary of findings for the main comparison. Routine antibiotic prophylaxis compared to no treatment or placebo for preventing infections in women who had normal vaginal births

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Comparison 1. 1. Antibiotic prophylaxis versus no treatment/placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Endometritis Show forest plot	2	1364	Risk Ratio (M‐H, Fixed, 95% CI)	0.28 [0.09, 0.83]

2 Urinary tract infection Show forest plot	2	1706	Risk Ratio (M‐H, Random, 95% CI)	0.25 [0.05, 1.19]

2.1 Short‐duration prophylaxis	1	1291	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.18, 1.45]
2.2 Long‐duration prophylaxis	1	415	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.03, 0.46]
3 Wound infection (episiotomy dehiscence) Show forest plot	2	1364	Risk Ratio (M‐H, Random, 95% CI)	0.78 [0.31, 1.96]

4 Adverse effects of antibiotics (skin rash) Show forest plot	2	1706	Risk Ratio (M‐H, Fixed, 95% CI)	3.03 [0.32, 28.95]

5 Length of maternal hospital stay ‐ days Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

6 Cost of care (cost of antibiotic prophylaxis, prolonged hospitalisation and treatment of endometritis) Show forest plot			Other data	No numeric data

Comparison 1. 1. Antibiotic prophylaxis versus no treatment/placebo

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