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ANTIBIOTIC PROPHYLAXIS REGIMENS AND DRUGS FOR CESAREANSECTION

Hopkins L, Smaill F

Date of most recent substantive amendment: 1 November 1998This review should be cited as: Hopkins L, maill !" #ntibiotic proph$la%is re&imens and dru&s for cesareansection '(ochrane )eview*" +n: The Cochrane Library , +ssue 1, --." /%ford: 0pdate oftware"

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A B S T R A C T

Bak!"o#n$

roph$lactic antibiotics for cesarean section have been shown to reduce the incidence of maternalpostoperative infectious morbidit$" 2an$ different antibiotic re&imens have been reported to be

effective"

O%&'(i)'s

The ob3ective of this review was to determine which antibiotic re&imen is most effective inreducin& the incidence of infectious morbidit$ in women under&oin& cesarean section"

S'a"* S("a('!+4e searched the (ochrane re&nanc$ and (hildbirth 5roup trials re&ister and the (ochrane

(ontrolled Trials )e&ister" The date of the most recent search was /ctober 1998"

S'l'(ion C"i('"ia

)andomi6ed trials that included women under&oin& cesarean section were included" Trials werere7uired to compare at least two different antibiotic re&imens" Trials that compared placebo with a

sin&le antibiotic re&imen were not included as these are studies which have been anal$6ed inanother (ochrane review"

Da(a oll'(ion an$ anal+sisData were e%tracted from each publication independentl$ b$ the reviewers" )eviewers were notblinded to the authors or sources of the articles" The primar$ outcome variable was endometritis

but data on other infectious complications were collected where provided"

Main R's#l(s

!ift$one trials published between 199 and 199 were included in the review and four weree%cluded from the review" The followin& results refer to reductions in the incidence ofendometritis" ;oth ampicillin and first &eneration cephalosporins have similar efficac$ with an odds

ratio '/)* of 1" '9


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endometritis and wound infection for women havin& elective 'planned* cesarean section as well as

those havin& emer&enc$ procedures 'adilla 198.? 2ohamed 1988*"

4hile it is clear that women under&oin& cesarean section benefit from proph$lactic antibiotics, it is

not clear whether an$ one particular a&ent is the dru& of choice" 2an$ different dru& re&imenshave been reported to be effective in decreasin& postoperative infectious morbidit$" To date,

penicillin, ampicillin, ticarcillin, me6locillin, piperacillin, imipenam, metronida6ole, clindam$cin,

&entamicin, tobram$cin, cefa6olin, cephalothin, ceforanide, cefonicid, cefuro%ime, cefta6idime,cefo%itin, cefamandole, cephradine, cefotetan and cefota%ime have been used for cesarean sectionproph$la%is and all have demonstrated efficac$ either alone or in combination with another dru&"

ome of these dru&s have activit$ a&ainst a narrow ran&e of potential patho&ens 'e&metronida6ole, &entamicin*, others specificall$ have additional anaerobic activit$ 'e& cefo%itin and

cefotetan* and $et others have ver$ broadspectrum covera&e 'imipenem*" Their pharmacokineticproperties 'e& serum half life* also differ"

ince there are an overwhelmin& number of effective dru&s available attempts to define anantibiotic re&imen of choice have been problematic" +deall$, such a dru& re&imen should be: '1*

proven effective in welldesi&ned prospective, randomi6ed, doubleblind clinical trials, '* activea&ainst the ma3orit$ of patho&ens likel$ to be involved, '.* attain ade7uate serum and tissue

levels throu&hout the procedure, '* not associated with the development of antimicrobialresistance, '


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+n addition, data were collected 'where available* on adverse events of treatment 'e& aller&ic and

other to%ic reactions, antibiotic associated diarrhea, development of bacterial resistance*,maternal len&th of sta$ and costs, and neonatal outcomes"

S E A R C H S T R A T E G Y F O R I D E N T I F I C A T I O N O F S T U D I E S

ee: (ochrane re&nanc$ and (hildbirth 5roup search strate&$

This review has drawn on the search strate&$ developed b$ the re&nanc$ and (hildbirth 5roup asa whole" The primar$ source of studies was the review &roup@s trials re&ister the re&nanc$ and(hildbirth 5roup@s peciali6ed )e&ister of controlled trials" ee )eview 5roup@s details for more

information" +n addition, the (ochrane (ontrolled Trials )e&ister was searched" The date of lastsearch was /ctober 1998"

M E T H O D S O F T H E R E V I E W

#ll potential trials were selected for eli&ibilit$ accordin& to the criteria specified in the protocol anddata were e%tracted from each publication b$ two reviewers" #n$ discrepancies were resolved b$discussion" +n addition to the main outcome measures listed above, information on the settin& ofthe stud$ 'countr$, t$pe of population, socioeconomic status*, a detailed description of the

antibiotic re&imen used 'dru&, dose, fre7uenc$ and timin&*, and definitions of the outcomes 'ifprovided* were collected" #n intent to treat anal$sis was performed where possible"

Trials were assessed for methodolo&ical 7ualit$ usin& the standard (ochrane criteria of ade7uac$of allocation concealment: ade7uate '#*, unclear ';*, inade7uate '(*, or that allocation

concealment was not used 'D*" +nformation on blindin& of outcome assessment and loss to followup were collected"

The main comparison of an$ treatment versus another treatment will not be stratified accordin& tothe indication for cesarean section"

eparate comparisons of different antimicrobial re&imens, &rouped where appropriate b$ spectrumof activit$, were made" +f there were sufficient trials, separate comparisons were made between

the timin& of antibiotic administration, the number of doses &iven and the route of administration'whether s$stemic or lava&e*"

ummar$ relative risks were calculated usin& a fi%ed effects model 'if there is no si&nificanthetero&eneit$ between trials*"

D E S C R I P T I O N O F S T U D I E S

!or a detailed description of studies see table of @ (haracteristics of included studies@"

#ll fift$one trials included in the review were conducted in industriali6ed countries '0nited tates,(anada, +srael, +tal$, wit6erland or The Netherlands*" (riteria listed to define the presence of

outcome variables of interest 'e& endometritis* were remarkabl$ consistent across trials"#ntibiotics for proph$la%is were administered after the cord was clamped in all but three of thetrials" The antimicrobial a&ents used in the trials included ampicillin, penicillin, imipenem,

cefa6olin, cephalothin, cephapirin, cefotetan, cefamandole, cefuro%ime, cefmeta6ole, cefo%itin,piperacillin, cefota%ime, cefta6idime, ceftria%one, me6locillin, mo%alactam, cefonicid, cefti6o%ime,

ticarcillin, &entamicin, clindam$cin, ceforanide, and metronida6ole" Two studies were published inthe 19-s, thirt$seven in the 198-s and twelve in the 199-s" /nl$ three studies could be found

that were eli&ible for inclusion where proph$lactic antibiotics were administered preoperativel$"The vast ma3orit$ of studies that administered proph$lactic antibiotics preoperativel$ were

placebocontrol trials with no additional treatment arms" Therefore, these studies were not eli&iblefor inclusion"

M E T H O D O L O G I C A L Q U A L I T Y!or detailed information on methods, see table of @(haracteristics of included studies@"

The methodolo&ical 7ualit$ of the studies overall was e%cellent" #lmost all of the studies were

intention to treat anal$ses and for some, it was possible to convert them where necessar$ datawas included"

R E S U L T S

The results of the metaanal$sis indicate that both ampicillin and first &eneration cephalosporinshave similar efficac$ in the reduction of maternal infectious morbidit$ followin& cesarean section"

!urther, it is not onl$ the relativel$ minor outcomes of febrile morbidit$ and endometritis that aree7uivalent with the different antibiotic re&imens, but serious infections as well" There is no

evidence that a more broadspectrum a&ent produces &reater efficac$ in the reduction ofinfectious morbidit$ followin& cesarean section" There is no evidence from this metaanal$sis to

recommend multiple doses of antibiotics" There appears to be no difference in efficac$ based on

whether the antibiotic is administered s$stemicall$ or b$ a lava&e route" There is insufficientevidence upon which to base a recommendation re&ardin& the optimal timin& of administration"


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D I S C U S S I O N

#ntibiotic proph$la%is can be e%pected to produce a si&nificant reduction in the incidence of

maternal infectious morbidit$" The t$pe of a&ent used proph$lacticall$ as well as the optimaltimin& of administration have been widel$ studied and discussed in the literature" +t is interestin&

to note that ver$ few trials have been published since the late 198-s on this sub3ect"

The results of this review indicate that both ampicillin and first &eneration cephalosporins are

appropriate choices for antibiotic proph$la%is for cesarean section" $stemic administration ofthese a&ents is recommended based on the results of this review"

The results indicate that a multiple dose re&imen does not offer an$ added benefit when comparedwith sin&le dose re&imens" !urthermore, sin&le dose re&imens are likel$ to be less e%pensive" The

advanta&es of a sin&le dose re&imen are obvious and mi&ht ensure universal utili6ation ofproph$lactic antibiotics for cesarean section, especiall$ in underresourced countries"

There is insufficient data upon which to offer a recommendation concernin& timin& ofadministration 'preoperative versus after cord clampin&* of proph$lactic antibiotics for cesarean

section" Nearl$ all published trials since 198 have administered the antimicrobial a&entimmediatel$ after the cord is clamped" rior to this, proph$lactic a&ents were adminstered pre

operativel$" This rather abrupt chan&e in practice followed the publication of prospectiverandomi6ed, placebo controlled trial demonstratin& that proph$lactic ampicillin administered after

the cord was clamped was as effective in decreasin& maternal morbidit$ as ampicillin &iven prior tothe procedure '5ordon 199*" 0nfortunatel$, no stud$ of sufficient si6e has $et been published

indicatin& whether preoperative administration or administration after the cord is clamped is moreeffective" 0ntil more evidence is available, timin& of administration ma$ remain discretionar$" Themost important &oal should be to ensure that all women under&oin& cesarean section receiveproph$lactic antibiotics and the a&ent of choice should be either ampicillin or a first &eneration

cephalosporin" (lindam$cin is an appropriate alternate choice for penicillinaller&ic women"

R E V I E W E R ' S C O N C L U S I O N S

Implia(ions /o" p"a(i';oth ampicillin and first &eneration cephalosporins represent &ood choices for proph$la%is in

women under&oin& cesarean section" 2ore costl$ e%tendedspectrum penicillins, second or third&eneration cephalosporins and combination re&imens have not been demonstrated to be more

effective" There is no evidence to su&&est that a multiple dose re&imen is of &reater benefit to thewoman than a sin&ledose re&imen"

Implia(ions /o" "'s'a"*

There will continue to be debate both in the literature and in clinical practice re&ardin& the optimaltime for administration of proph$lactic antibiotics" There is currentl$ insufficient evidence upon

which to base a recommendation re&ardin& the optimal timin& of antibiotic administration" This7uestion will not be resolved until a randomi6ed trial of sufficient si6e is completed comparin& pre

operative administration versus administration immediatel$ after the cord is clamped"

A C K N O W L E D G E M E N T S

None"

P O T E N T I A L C O N F L I C T O F I N T E R E S T

None known"

T A B L E S

C*a"a('"is(is o/ inl#$'$ s(#$i's

Detach table

S(#$+ B'ni!o 0123

2ethods )andomi6ed, double blind stud$"

articipants 4omen under&oin& (A"

NB.> enrolled: 5roup 1, NB1>9 vs 5roup , NB1"

Total >. women e%cluded because of e%clusion criteria and loss to followup '5roup 1,NB.. and 5roup , NB.-*"

C%clusion criteria: antibiotic use in last da$s, dru& aller&$, renal or hepatic d$sfunction,infection at time of enrollment, intention to breast feed within hours of deliver$"


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+nterventions 5roup 1: & iv piperacillin after cord clamped with repeat doses at and 8 hours post

first dose"

5roup : & cefo%itin after cord clamped with repeat doses at and 8 hours postfirst

dose"

/utcomes !ebrile morbidit$ 'temp .8 % occasions, > hours apart, not included first hour postoperation

5roup 1: -A1.> vs 5roup : >A1"

4ound infection 'criteria not specified*

5roup 1: 1A1.> vs 5roup : 1-A1"

Notes Not an intention to treat anal$sis, cannot convert due to lack of data (ointervention:

#dditional s$stemic antibiotics were administered to patients in 5roup 1 and 9 patientsin 5roup for reasons other than infections at the operative site '#uthors stated the$

repeated the anal$sis e%cluded these patients and no si&nificant difference in the resultswere found*" #dverse dru& reactions: 5roup 1: episodes of pruritis and 5roup : 1 case

diarrhea and 1 case of d$spnea (ountr$: 0""

#llocationconcealment

#

S(#$+ B'"k'l'+ 0114

2ethods )andomi6ed trial, not blinded"

articipants #ll patients under&oin& (esarean section"

NB1-, patients e%cluded from the stud$ because of the followin& e%clusion criteria"C%clusion criteria: a&eE18, dru& aller&$, received antibiotics in last hours, received

steroids for fetal lun& maturit$ or medical illness, renal or hepatic d$sfunction, evidenceof +#+"

+nterventions 5roup 1: & cefota%ime in 1 L N b$ uterine lava&e"

5roup : 1 & cefota%ime iv after cord clamped with repeat dose at > and 1 hours"

/utcomes !ebrile morbidit$ 'temp .8 % occassions > hours apart, e%cludin& first hourspostpartum"

5roup 1: 9A


6/40

da$s, alcohol or dru& abuse"

+nterventions 5roup 1: & cefotetan iv after cord clamped, two additional doses of either cefotetan or

placebo were &iven at > and 1 hours after first in3ection"5roup : & cefo%itin as per re&imen above"

/utcomes !ailure rate '+nfectious morbidit$ included evidence of an$ infection includin&

endometritis, wound infection, pelvic abscess and FT, fever % also included .8*

5roup 1: 1-A111 vs 5roup : >A"

Notes (ountr$: (anada"

#llocation

concealment

#

S(#$+ Boo(*%+ 0125

2ethods )andomi6ed trial, table of random numbers used b$ circulatin& nurse to allocate patients"+ntention to treat anal$sis"

articipants #ll women under&oin& primar$ (A in a > month period"

C%clusion criteria: dru& aller&$, recent use of antibiotics 'not specified* or known

infectious process"

+nterventions 5roup 1: +ntraoperative irri&ation, cefo%itin & in 1L N, NB


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4ound infection 'cellulitis andAor purulent draina&e*:

5roup 1: .A19 vs 5roup : .A18 vs 5roup : A94ound infection 'fever, er$thema, induration, tender andAor purulent draina&e fromwound*"


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5roup 1: A> vs 5roup : -A9

Cndometritis 'fever or uterine tenderness withAwo foul lochia:

5roup 1: >A> vs 5roup : .A9

0T+ ' fever, d$suria and pos culture*"5roup 1:A> vs 5roup : -A9"

Notes (onverted stud$ to intention to treat model 'NB11>*, outcome of last women not

included in stud$ she underwent (esareanh$sterectom$"

#bove 0T+, wound infection and endometritis are distinct from @febrile morbidit$@"

(ountr$: 0""


;

S(#$+ Das*o 0123

2ethods )andomi6ed, doubleblind control trial"

(omputer&enerated numbers usin& mi%ed con&ruential method"

+ntention to treat anal$sis"

articipants 4omen under&oin& (A between December 198 and 2a$ 198, all indications"

C%cusion criteria: dru& aller&$, antibiotic therap$, known infectious process"

+nterventions +rri&ation solutions: 'information from placebo arm e%cluded*" #ll solutions contained &

dru& in 8-- cc N with a vitamin added to each for dis&uise"

5roup 1: (ephapirin sodium5roup : (ephamandole nafate

5roup .: 2o%alactam disodium5roup : #mpicillin sodium"

/utcomes Cndometritis 'temp ."8, uterine tenderness, pelvic irritation without other locali6in&

si&ns5roup 1: 8A- vs 5roup : .A> vs 5roup .: 1.A9 vs 5roup : >A-"

0T+ ' 1--,--- or&s*

5roup 1:1A- vs 5roup : A> vs 5roup .: 1A9 vs 5roup :


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+nterventions 5roup 1: 1 & iv cefa6olin after cord clamped and two further doses of 1 & iv at 8 hour

intervals 'nB*"

5roup : cefonicid 1 & after cord clamped 'nB1-.*"

/utcomes No wound infections"!ebrile morbidit$ 'temp ."8 % , hour apart, not first hours postoperation or

temp .8 first hours*

5roup 1: 18A9> vs 5roup : 1 vs 5roup : .A1-."

Notes Hospital sta$ 'mean*: 5roup 1: " da$s vs 5roup : " da$s"

(ountr$: 0""

#llocation

concealment

#

S(#$+ Ellio( 0127

2ethods )andomi6ed, placebo control, blinded 'mechanism not specified*"

(ode broken if postop infection developed"

lacebo data e%cluded from this review"

+ntention to treat"

articipants 4omen under&oin& (A"+nclusion: )/2, at least one FC

C%clusion : dru& aller&$, temperature .">, +#+"

+nterventions 5roup 1: #mpicillin & after cord clamped, then 1& iv 7>h until eatin&, then *"

/utcomes !ebrile morbidit$ 'temp ."8 %, > hours apart, e%cludin& first hours*:


10/40

5roup 1:.A. vs 5roup : 1"

Cndometritis 'fever, uterine tenderness, foul dischar&e*: 5roup 1: .A. vs 5roup :

1.A>"

0T+ 'fever, d$suria or pos culture*:5roup 1: -A. vs 5roup : 1A>"

4ound infection 'fever, cellulitis and e%udate*

5roup 1: -A. vs 5roup : 1A>"/ther serious infection 'FT, sepsis*:5roup 1: -A. vs 5roup : A>"

Notes 2ean duration of hospital sta$: 5roup 1: "1 da$s vs 5roup : hours apart, e%cludin& first hours postoperation*:

5roup 1: A.9 vs 5roup : .A vs 5roup .: A.8"No wound infections, or cases of sepsis"

Cndometritis 'fever, uterine tenderness, foul dischar&e, no other etiolo&$ apparent*:

5roup 1: A.9 vs 5roup : A vs 5roup .: A.8

0T+ 'fever, urinar$ s$mptoms or positive culture*:5roup 1: -A.9 vs 5roup : 1A vs 5roup .: -A.8"

Notes (ountr$: 0""

#llocation

concealment

;

S(#$+ Fa"o 0114

2ethods )andomi6ed trial"

Numbers in each treatment &roup unbalanced, reason &iven: stud$ is on&oin&,

randomi6ation not $et complete"


articipants 4omen for (A, indi&ent population, Harris count$, Te%as

+nclusion: labor hours, afebrile, no antibiotic therap$ in previous da$s"C%clusion: dru& aller&$

NB1


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'cefo%itin 1&AnB1


12/40

Notes Lan&ua&e: !rench"

No information on hospital sta$, adverse dru& reactions or neonatal outcomes"

(ountr$: (anada"

#llocation

concealment

#

S(#$+ Galask 0122

2ethods )andomi6ed"Table of random numbers in :1 ratio so twice as man$ participants received cefotetan"

Not intention to treat, cannot convert"

articipants 4omen for primar$ or repeat (A"

+nclusion: a&e 18 and 1

hours after the first 'nB9*"

/utcomes Cndometritis 'criteria not specified*:5roup 1: 19A1> vs 5roup : A9"

4ound infection 'criteria not specified*:5roup 1: A1> vs 5roup : A9"

0T+ 'criteria not specified*:5roup 1: 1A1> vs 5roup : A9"

!ebrile morbidit$ 'criteria not specified*:

5roup 1: 1A1> vs 5roup : -A9"

Notes (ountr$: 0""

#llocation

concealment

;

S(#$+ Gall 0126

2ethods )andomi6ed, doubleblind"Not intention to treat, cannot convert due to lack of data"

articipants 4omen under&oin& primar$ (A presumed to be at increased risk"

+nclusion: labor or )/2 > hours, scalp clip 9 hours, +0(, . or more va&inal

e%aminations"

N B 1. e%cluded after randomi6ation due to errors in antibiotic administration"

+nterventions 5roup 1: iperacillin & iv after cord clamped 'nB>-*"5roup : iperacillin & iv after cord clamped and repeat same dose at and 8 hours

post first dose 'nB*"

/utcomes Cndometritis criteria not specified:

5roup 1: 8A>- vs 5roup : .A"

Notes (ountr$: 0""


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#llocation

concealment

#

S(#$+ Gon'n 0123

2ethods )andomi6ed, doubleblind stud$"

Not intention to treat, cannot convert, data not supplied"


C%clusion: fever, infection in labor, antibiotic therap$ in last 8 hours, separate indicationfor proph$la%is, dru& aller&$"

NB 1 randomi6ed, 9 e%cluded due to protocol deviation"

+nterventions 5roup 1: (efamandole & in 1 l N, +rri&ation 'nB1-1*"

5roup : (efamandole & iv after cord clamped and repeat same dose 7>h % < doses

'nB1-*"

/utcomes Cndometritis 'temperature .8 % da$s, e%cludin& first hours, uterine tenderness,with or without foul lochia, no other obvious cause for infection*:

5roup 1:11A1-1 vs 5roup : 1 and 1hour postoperation 'nB


14/40

Not intention to treat, cannot convert"


+nclusion: a&e 18, no dru& aller&$, in labor or )/2 present"C%clusion: elective (A, current antibiotic therap$, chronic renal or hepatic disease"

+nterventions 5roup 1: (efa6olin 1 & iv after cord clamped 'NB>.*"

5roup : (efo%itin & iv after cord clamped 'NB>>*"

5roup .: (efota%ime 1 & iv after cord clamped 'NB>-*"

/utcomes Cndometritis 'temp elevation, uterine tenderness, foul lochia, leukoc$tosis 1. vs 5roup : 9A>> vs 5roup .: -"0T+: '. vs 5roup : -A>> vs 5roup .: -A>-";acteremia 'criteria not specified*:

5roup 1: A>. vs 5roup : 1A>. vs 5roup .: -A>-"

Notes (ountr$: 0""


;

S(#$+ Ha"('"( 0126

2ethods )andomi6ed"

Not intention to treat anal$sis, cannot convert since data not included"


C%clusion: infection, antibiotic therap$ in last hours, temperature .8, dru& aller&$"

1


15/40

hepatic or renal disease"

NB189, vs 5roup : -"Cndometritis 'fever, foul li7uor, or uterine tenderness*

5roup 1: >A> vs 5roup : .A>-"0T+ 'fever, pos culture, with or without d$suria*:

5roup 1: A> vs 5roup : A>-"4ound infection 'fever, cellulitis, or e%udate*:

5roup 1: 1A> vs 5roup : 1A>-"

Notes (ountr$: (anada"


#

S(#$+ I(sko)i(: 0161

2ethods tate women assi&ned at random accordin& to da$ of admission"

Three &roups of women, one a placebo &roup" /b3ective of this review is to comparedifferent re&imens, therefore, the data from the placebo arm is e%cluded"

articipants 4omen under&oin& (A for various reasons, NB1


16/40


lacebo arm and related data e%cluded due to ob3ectives of this review"

articipants 1-- women re7uirin& (AC%clusion: elective (A, )/2 E .h, or fewer va&inal e%ams, temperature .8, dru&

aller&$ )/2 hours"

+nterventions 5roup 1: (efa6olin 1 & iv after cord clamped 'nB


17/40

articipants #ll women became candidates when the decision was made to perform primar$ (A" #

few women for repeat (A became candidates if the$ presented with )/2, labor, obesit$

or chronic medical conditions associated with increased infectious risk"

C%clusion criteria: si&ns of infection 'temp ".8, +#+*, aller&$ to penAcephalosporin,antibiotic treatment in last 1 da$s, unable to obtain consent"

+nterventions NB1-"

5roup 1: 1 & cephalothin iv Ion call to /)I and a&ain two and ei&ht hours postoperation

'nB8*"

5roup : 1 & cefamandole iv, timin& of administration as above 'nB.*"

/utcomes !ebrile morbidit$ 'temperature .8 % da$s, e%cludin& first hours*5roup 18A8? 5roup 1A."

!ebrile morbidit$ 'above* then broken down b$ cause:Cndometritis 'fever, uterine tenderness*

5roup 1 1


18/40

#llocation

concealment

;

S(#$+ L'on'((i 0121

2ethods )andomi6ed, blinded, placebo control trial"

lacebo arm data e%cluded from this review"

+ntention to treat"

articipants atients for (A 'primar$, after onset of labor*"Lar&el$ a low socioeconomic, indi&ent population"

+nterventions 5roup 1: iperacillin & iv after cord clamped 'NBh 'NB


19/40

5roup : (ephapirin & in 1L N b$ irri&aiton 'NB*"

/utcomes Cndometritis 'temp 1--", uterine tenderness, foul lochia, no other cause for infection*:

5roup 1: 1A1 vs 5roup : A"4ound infection: No cases"

0T+ '1- e%p < or&sAml*: 5roup 1: A1 vs 5roup : 1A"

Notes 2ean hospital sta$: 5roup 1: "9 da$s vs 5roup : "8 da$s" No information on neonatal

morbidit$ or dru& reactions" (ountr$: 0""

#llocation

concealment

#

S(#$+ L'is 0114

2ethods )andomi6ed, doubleblind, control"

(ontrol arm data not included due to ob3ective of review"

Not intention to treat 'cannot convert*"

articipants +ndi&ent population of women under&oin& (A"NB.9>, 9 e%cluded due to incomplete charts"

C%clusion: antibiotic therap$ in last 1 da$s, dru& aller&$"

+nterventions 5roup 1: Ticarcillin < & in 1" L N, b$ irri&ation 'NB1 and 1 hours post

operation 'NB>-*"

5roup : (efa6olin 1 & iv after cord clamped and further doses at > and 1 hours post

operation 'NB-*"

5roup .: (efota%ime 1 & iv after cord clamped and further doses at > and 1 hours

postoperation 'NB


20/40

/utcomes Cndometritis 'temperature .8, foul lochia, uterine tenderness*: 5roup 1: A>- vs 5roup

: .A- vs 5roup .: A- vs 5roup : 1A- vs 5roup .: 1AA18 da$s" #lso recorded same for @failure

an$ infectious complication@: 5roup 1: 8"1 da$s vs 5roup : 8"1 da$s vs 5roup .:

"1 da$s"

(ountr$: (anada"

#llocation

concealment

#

S(#$+ Mans#'(o 0121

2ethods )andomi6ed trial"+ntention to treat"

articipants Nonelective (A"

C%clusion: dru& aller&$, renal d$sfunction, temperature .8, antibiotic therap$ in last 8

hours

+nterventions 5roup 1: +mipenem *"

/utcomes Cndometritis 'criteria not specified*: 5roup 1: 1A vs 5roup : 1A>"

!ebrile morbidit$ 'criteria not specified*: 5roup 1: -A vs 5roup : 1A>"

Notes Lan&ua&e: +talian" (ountr$: +tal$"

No data on hospital sta$, neonatal morbidit$ or dru& reactions"


#

S(#$+ Mass' 0122

2ethods atient allocation b$ hospital +D number"

+ntention to treat"

articipants 4omen for nonelective (A, labor or )/2, NB


21/40

#llocation

concealment

(

S(#$+ Ma(*'li'" 0117

2ethods ub3ects alternatel$ assi&ned to treatment &roups"

+ntention to treat"

articipants 4omen for (A"

+ndi&ent population"C%clusion: +#+, evidence of other infection"

+nterventions 5roup 1: (efa6olin & iv after cord clamped and saline irri&ation of abdomen 'NB1*"

5roup : (efo%itin & iv and further doses at and 8 hours postoperativel$ 'NB*"

/utcomes Cndometritis 'temp .8, uterine tenderness, positive culture, no other identifiable cause

of infection*5roup 1: A> vs 5roup : A"

4ound infection 'no criteria stated*

5roup 1: A> vs 5roup : A"

0T+ 'no criteria stated* 5roup 1: 1A> vs 5roup : -A"

Notes (ountr$: 0""

2ean hospital sta$: 5roup 1: "< da$s vs 5roup : "< da$s"

#llocation

concealment

#

S(#$+ MG"'!o" 0122

2ethods )andomi6ed, multicentre trial"


22/40

4omen assi&ned in :1 ratio for cefotetan accordin& to computer &enerated

randomi6ation codes"

Not intention to treat 'cannot convert*

articipants #dults '18 *"

5roup : #s above e%actl$ but with addition of #mpicilin ' &* and tetrac$cline '1"< &* per

da$, to complete . da$s 'NB8*"

/utcomes !ebrile morbidit$ 'temperature .8 % occasion, hours apart, e%cludin& first hours*:

5roup 1: 1A9> vs 5roup : 11A8"

Cndometritis: 5roup 1: A9> vs 5roup : .A8"4ound infection: 5roup 1: vs 5roup : >A8"

0T+: 5roup 1: .A9> vs 5roup : 1A8"

'No criteria specified for above three*

/ther serious infection 'sepsis, pneumonia*:

5roup 1: 1A9> vs 5roup : 1A8"

Notes +ntervention not clear re&ardin& fre7uenc$ and route of antibiotics"No data on hospital sta$, neonatal morbidit$"

(ountr$: +srael"

#llocation

concealment

(

S(#$+ O-L'a"+ 0123


23/40

2ethods )andomi6ed, nonblind"

)andomi6ation done b$ hospital number"

+ntention to treat"

articipants 4omen under&oin& primar$ (A after onset of labor"

+ndi&ent population"C%clusion: febrile, dru& aller&$, infection present"

+nterventions 5roup 1: #mpicillin & iv @intraoperativel$@ and additional doses 7>h 'NB>1*"

5roup : #mpicillin & iv as above plus addition of 5entamicin 1m&Ak& after cord

clamped and 78h % > doses 'NB>*"

/utcomes !ebrile morbidit$ 'temperature ."9 %, > hours apart, at least hours post

operativel$*: 5roup 1: 19A>1 vs 5roup : 1A>"Cndometritis 'tender uterus, foul lochia, temperature ."9*:

5roup 1: 1.A>1 vs 5roup : "

4ound infection 'no criteria*:

5roup 1: 1A>1 vs 5roup : 1A>"

0T+ 'no criteria*: 5roup 1: 1A>1 vs 5roup : 1A>"

Notes 2ean hospital sta$: 5roup 1: >" da$s vs 5roup : "

+nfectious morbidit$ 'endometritis JA 0T+*:

5roup 1: 9A- vs 5roup : 8A>"4ound infection: 5roup 1: -A9- vs 5roup : 1A>"

Notes Discrepanc$ in numbers between &roups $et state @randomi6ed@"

(ountr$: 0""

#llocation

concealment

;

S(#$+ P'('"son 0114

2ethods )andomi6ed, doubleblind"

+ntention to treat"


24/40

articipants 4omen under&oin& nonelective (A 'defined as in labor with )/2*"

C%clusion: dru& aller&$, patient on antibiotics, those with evidence of infection, those

re7uirin& ;C proph$la%is"

+nterventions 5roup 1: (efa6olin & iv after cord clamped 'NB*"

5roup : (efamandole & iv after cord clamped 'NBA vs 5roup : >A


25/40

antibiotic therap$ in last da$s, @protocol failures@"

+nterventions 5roup 1: (efo%itin & iv after cord clamped 'NB>>*"

5roup : (efo%itin & iv after cord clamped and additional doses of 1& iv at > and 1hours postoperativel$ 'NB*"

/utcomes !ebrile morbidit$ 'temperature .8 for hours, e%cludin& first hours after (A*:

5roup 1: 19A>> vs 5roup : 11A"

Cndometritis 'fever, foul lochia, andAor uterine tenderness * 5roup 1:> vs 5roup :

1A"

4ound infection 'palpable induration, wound dehiscence andAor pus*:

5roup 1: A>> vs 5roup : 1A"0T+ '1- e%p < or&AmL*: 5roup 1: .A>> vs 5roup : -A"

Notes (ountr$: The Netherlands"

No data on hospital sta$, neonatal outcomes, dru& reactions"

#llocation

concealment

#

S(#$+ Sal(:man 0123

2ethods )andomi6ed double blind stud$, mechanism not stated"

articipants 1 hours"

C%clusion criteria: temperature .8, si&ns of active infection, antimicrobial use within last hours, dru& aller&$"

+nterventions 5roup 1: 2e6locillin & iv after cord clamped 'sin&le dru& dose*, nBA


26/40

articipants #ll women under&oin& (A with )/2 for . hours or more, all were 18 $ears of a&e"

C%clusion: dru& aller&$, antibiotic therap$ in last hours, women were @likel$@ to receive

other antibiotics, evidence of intrapartum infection"

+nterventions 5roup 1: (eforanide & iv after cord clamped 'NB.*"

5roup : (eforanide & in 1L N b$ irri&ation 'NB*"

/utcomes Cndometritis 'purulent cervical dischar&e, uterine tenderness, temperature .8*:

5roup 1: A. vs 5roup : .A"

4ound infection 'purulent draina&e from wound*

5roup 1: -A. vs 5roup : 1A"

0T+ '1- e%p < or&AmL with fever, d$suria, fre7uenc$ or (F# tenderness*: 5roup 1: A.vs 5roup : 1A"

!ebrile morbidit$ 'temperature .8 % da$s consecutivel$, e%cludin& first hours*:5roup 1: A. vs 5roup : >A"

Notes (ountr$: 0""

2ean hospital sta$: 5roup 1: " da$s vs 5roup : >" hour 'NB19*"

5roup : (efuro%ime


27/40

/utcomes Cndometritis 'uterine andAor adne%al tenderness, accompanied b$ fever with or without

purulent va&inal dischar&e: 5roup 1: >:


28/40

5roup 1: A- vs 5roup : -A9

Notes (ountr$: 0""

2ean hospital sta$: 5roup 1: >"1 da$s vs 5roup : >" da$s"

#llocation

concealment

;

S(#$+ ?'lls 0115

2ethods )andomi6ed trial, placebo control"

lacebo data e%cluded due to ob3ective of this review"+ntention to treat"

articipants 4omen under&oin& nonelective (A"

+nterventions 5roup 1: 2etronida6ole 1 & pr after cord clamped 'NB8*"

5roup : 2etronida6ole 1 & pr after cord clamped and (efuro%ime


29/40

#llocation

concealment

(

(diff B clostridia difficile(D B cephalopelvic disproportion(A B cesarean section+#+ B intraamniotic infection

+D B identit$+L B one litre+0( intrauterine pressure catheter+F B intravenousN B normal saline/ B b$ mouthH B ever$ four hours)/2 B rupture of membranes;C B subacute bacterial endocarditisFT B septic pelvic vein thrombophlebitis)+ B sur&icall$ related infection)/2 B spontaneous rupture of membranesFC B spontaneous va&inal e%amination0(L# B universit$ of (alifornia at Los #n&eles0T+ B urinar$ tract infection4;( B white blood cell count

M) B $ear

C*a"a('"is(is o/ '=l#$'$ s(#$i's

S(#$+ R'ason /o" '=l#sion

D@#n&elo

198-

(omparison of short versus lon&course proph$lactic antibiotic treatment:

#uthors do not list dose of dru& at time of first administration, nor do the$ indicate the time ofadministration 'preoperative, cord clamp* The authors are not even clear about the identit$ of

the dru& which be&ins the proph$lactic re&imen"The$ state that it is a random stud$ but provide no details of mechanism"

Dealma

198-

#t the start of the stud$, two arms? one a no treatment arm, the other composed of women

&iven either cefamandole or penicillin plus &entamicin" +t would have been possible to tr$ anddissect important information from the stud$ e%cept that the$ chan&ed the antibiotic re&imen

after treatin&


30/40

;oothb$ ), ;enrubi 5, !errell C" (omparison of intravenous cefo%itin proph$la%is with intraoperative cefo%itin irri&ation for theprevention of postcesareansection endometritis" G )eprod 2ed 198?9'11*:8.-8."

Ca"lson 0114 published data onl$O(arlson (, Duff " #ntibiotic proph$la%is for cesarean deliver$: is an e%tendedspectrum a&ent necessar$P" /bstet

5$necol 199-?>'.*:...>"

Cono)'" 0125 published data onl$O

(onover 4, 2oore T" (omparison of irri&ation and intravenous antibiotic proph$la%is at cesarean section" /bstet5$necol 198?>.'>*:891"

C"om%l'*olm' 0126 published data onl$O(rombleholme 4, 5reen G, /hmmith 2, Dahrou&e D, DeKa$ F, )ideout #, weet )" (esarean section proph$la%is: comparison

of two doses with three doses of me6locillin" #G)+2 198?1.:1?.1'1*:1


31/40

;ako%i 0122 published data onl$OGakobi , 4eissman #, Qimmer C, aldi C" in&ledose cefa6olin proph$la%is for cesarean section" #m G /bstet

5$necol 1988?1?9'1-*:181..>"

L')in 0128 published data onl$OLevin D, 5orchels (, #ndersoen )" )eduction of postcesarean section infectious morbidit$ b$ means of antibiotic irri&ation" #m G

/bstet 5$necol 198.?1'.*:.>"

L'is 0114 published data onl$OLewis D, /tterson 4, Dunnihoo D" #ntibiotic proph$lactic uterine lava&e in cesarean section: a doubleblind comparison of saline,

ticarcillin and cefo%itin irri&ation in indi&ent patients" 2ed G 199-?8.'.*:>"

Lo#i' 0127 published data onl$OLouie TG, ;inns ;, ;askett T, )oss G, Koss G" (efota%ime, cefa6olin or ampicillin proph$la%is of febrile morbidit$ in emer&enc$

cesarean sections" (lin Therap 198?"

Mans#'(o 0121 published data onl$O2ansueto 5, Tomaselli !" Rrofilassi antibiotica in pa6ieti sottoposte a ta&lio cesareo non di ele6ione con +mipenem in Isin&le

doseI versus cefota%ime in Imultiple dosesIS" Cur )ev 2ed harm c 1989?11:>8"

Mass' 0122 published data onl$O

2asse #, Tur&eon , 5a$ N, Ferschelden 5" RCfficacite comparee de l@antibiotproph$la%iie par la cefo%itine en une ou trois dosesdans la cesarienneS" (an 2ed #ssoc G 1988?1.8:919"

Ma(*'li'" 0117 published data onl$O2athelier #" # comparison of postoperative morbidit$ followin& proph$lactic antibiotic administration b$ combined irri&ation andintravenous route or b$ intravenous route alone durin& cesarean section" G erinat 2ed 199?-:118"

MG"'!o" 0123 published data onl$O2c5re&or G, !rench G, 2akowski C" in&ledose cefotetan versus multidose cefo%itin for proph$la%is in cesarean section in hi&h

risk patients" #m G /bstet 5$necol 198>?1


32/40

)oe% #, u$enbroek G, vanLoenen #, #rts N" in&le versus threedose cefo%itin proph$la%is in caesarean section: a randomi6edclinical trial" Cur G /bstet 5$necol )eprod ;iol 198??.1:-91"

Sa"a)ola(: 0129 published data onl$O

aravolat6 L, Lee (, Drukker ;" (omparison of intravenous administration with intrauterine irri&ation with ceforanide fornonelective cesarean section" /bstet 5$necol 198>'*::>->>"

)eferences to studies awaitin& assessment

Ba*'"ai' 0116 ;aheraie #, 2odares 2, #6imi Kh, 2ahmodi 2" in&ledose cefa6olin proph$la%is for cesarean section" #cta /bstet 5$necol

cand 199?>:8"

L#((k#s 0116 Luttkus #, !iebelkorn G, Dudenhausen 4" #ntibiotic proph$la%is in cases of emer&enc$ caesarean section 'translated*" 5eburtsh u

!rauenheilk 199?


33/40

D#// 0127 Duff , mith N, Keiser G!" #ntibiotic proph$la%is in low risk cesarean section" G )eprod 2ed 198?:1..1.8"

Gi%%s 0167 5ibbs ), De(herne$ #H, chwar6 )H" roph$lactic antibiotics in cesarean section: a doubleblind stud$" #m G /bstet

5$necol 19?11:1-81-


34/40

47 0s( G'n'"a(ion C'p*alospo"in )s 7n$@8"$ G'n'"a(ion C'p*alospo"in

/utcome title

No" of

studies

No" of

participants

tatistical

method Cffect si6e

-1 !ebrile 2orbidit$ < 1--8 eto /) R9


35/40


/utcome title

No" of

studies

No" of

participants

tatistical

method Cffect si6e

-1 !ebrile 2orbidit$ < 1--8 eto /) R9 R-">8,

."8S


36/40


/utcome title

No" of

studies

No" of

participants

tatistical

method Cffect si6e

-1 !ebrile 2orbidit$ < 1--8 eto /) R9 R-"8.,

"18S

- Cndometritis 1 1. eto /) R9,

""S

- 0rinar$ Tract +nfection 1 1. eto /) R9,

1>"S

41 Ca"%ap'n'm )s 7n$@8"$ G'n'"a(ion C'p*alospo"in

/utcome title

No" of

studies

No" of

participants

tatistical

method Cffect si6e

-1 !ebrile 2orbidit$ 1 8 eto /) R9


37/40


/utcome title

No" of

studies

No" of

participants

tatistical

method Cffect si6e

-1 !ebrile 2orbidit$ < 1--8 eto /) R9S

-. 4ound +nfection . S

- Cndometritis 8 9.1 eto /) R9


38/40


/utcome title

No" of

studies

No" of

participants

tatistical

method Cffect si6e

-1 !ebrile 2orbidit$ < 1--8 eto /) R9>- eto /) R9


39/40

Title

An(i%io(i p"op*+la=is "'!im'ns an$ $"#!s /o"

'sa"'an s'(ion

)eviewer's* Hopkins L, Smaill F

(ontribution of reviewer's* +nformation not supplied b$ reviewer

+ssue protocol first published 1998A.

+ssue review first published 1999A

Date of most recent amendment +nformation not available

Date of most recent 0;T#NT+FC

amendment

1 November 1998

2ost recent chan&es +nformation not supplied b$ reviewer

Date new studies sou&ht but none found +nformation not supplied b$ reviewer

Date new studies found but not $et

includedAe%cluded

+nformation not supplied b$ reviewer

Date new studies found and

includedAe%cluded


Date reviewers@ conclusions section

amended


(ontact address Dr !iona maill

rofessor

Department of atholo&$ and 2olecular 2edicine

!acult$ of Health ciences, 2c2aster 0niversit$

)oom N91-- 2ain treet 4est

Hamilton

L8N .Q</ntario

(#N#D#

J1 9-<


40/40

Cditorial &roup code H2)C5

S O U R C E S O F S U P P O R T

E=('"nal so#"'s o/ s#ppo"(

No sources of support supplied

In('"nal so#"'s o/ s#ppo"(

No sources of support supplied

I n d e x T e r !

M'$ial S#%&'( H'a$in!s M'SH

#ntibiotic roph$la%is ? (esarean ection 2esh check words: !emale Human re&nanc$

U 0pdate oftware Ltd"#ll ri&hts reserved" No part of the data or procedures or pro&rams used for access to or the displa$ of the data in The

Cochrane Library ma$ be reproduced, chan&ed, translated, stored in a retrieval s$stem or transmitted in an$ form or b$an$ means without the prior permission of 0pdate oftware Ltd", e%cept in the case of copies intended for securit$backups or internal use"
http://parent.meshsinglesearch%28%22antibiotic%20prophylaxis%22%29/http://parent.meshsinglesearch%28%22cesarean%20section%22%29/http://parent.meshsinglesearch%28%22female%22%29/http://parent.meshsinglesearch%28%22female%22%29/http://parent.meshsinglesearch%28%22human%22%29/http://parent.meshsinglesearch%28%22pregnancy%22%29/http://parent.meshsinglesearch%28%22antibiotic%20prophylaxis%22%29/http://parent.meshsinglesearch%28%22cesarean%20section%22%29/http://parent.meshsinglesearch%28%22female%22%29/http://parent.meshsinglesearch%28%22human%22%29/http://parent.meshsinglesearch%28%22pregnancy%22%29/

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