Methods

'Divided randomly into two groups'; not placebo‐controlled.
Imbalance in group size not accounted for (58 vs 48).

Participants

Both elective and non‐elective cesarean deliveries.
Exclusion criteria: fever or obvious infection before operation.
Setting: University College Hospital, Ibadan, Nigeria.
Majority of patients from low socio‐economic class.

Interventions

Ampicillin 500mg before operation and 250mg 6 hourly for at least 7 days (intramuscularly until able to take orally) (n = 58) versus no antibiotics unless temperature 38 degrees C after the third postoperative day (n = 48). Both groups received curative doses of chloroquine.

Outcomes

Wound infection; urinary tract infection (not defined further); 'genital sepsis' (not defined further).

Notes

Episodes of 'genital sepsis' classified as endometritis.
Prophylaxis continued for 7 days.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized list of placebo or drug, kept in hospital pharmacy; code not broken until after patient classified as 'morbid' or 'non‐morbid'; placebo‐controlled.

Participants

Women undergoing cesarean section (criteria not specified).
Exclusion: evidence of clinical infection, history of penicillin allergy.
Setting: Johns Hopkins University, Baltimore, US; August 1970 ‐ January 1971.

Interventions

Cephalothin 1g IV on call to operating room, further 2g IV intra‐operatively and every 6 hours for 48 hours, then 500mg IM for additional 72 hours (n = 5) versus placebo (n = 7).

Outcomes

Morbidity (temperature > 100.9 degrees fahrenheit twice, 6 hours apart after first 48 hours or other clinical signs of infection); not separated. For this review, the authors' definition of morbidity has been classified as fever.

Notes

Part of a larger randomized trial of prophylactic antibiotics in gynecologic surgery; most patients (87%) were undergoing hysterectomy; only 12/300 patients enrolled underwent cesarean section.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Double blind, placebo controlled. 'Randomly divided into 2 groups'.
Discrepancy in group numbers (139 vs 120) not accounted for.

Participants

Both elective and non‐elective cesarean deliveries.
Exclusion criteria: antibiotics within 2 weeks; pyrexia; any visible infection; penicillin allergy; known medical illness that might cause pyrexia; internal fetal scalp or uterine monitoring.
Setting: College Hospital, New Jersey, October 1977 to June 1980. Women 'predominantly black (90%) and socioeconomically disadvantaged'.

Interventions

Ticarcillin 6g intravenously within 15 minutes of cord clamping (n = 139) versus saline placebo (n = 120). Subset of 22 in each group received ticarcillin 3g/saline 6‐8 hours postoperatively (results similar so authors combined results with single dose group).
No postoperative antibiotics unless pyrexial >38 degrees C after day 1.

Outcomes

Endomyometritis (pyrexia, uterine tenderness and no evidence of other infection).

Notes

Authors' definition of low and high risk not comparable to definitions for elective/non‐elective used in this review.
Results for adolescent group (aged 15‐18) reported in J Adolescent Health Care 1984;5:163‐166. In that study, incidence of endomyometritis in elective section: 0% for treatment vs 43% for placebo (numbers not given).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized (computer‐based allocation), double‐blind, placebo controlled.
All patients accounted for; intent to treat analysis performed.

Participants

Women undergoing elective cesarean delivery. Exclusion: prior antibiotics within 2 weeks, allergy to penicillin or cephalosporin, rupture of membranes.
Setting: Durban, South Africa.

Interventions

Cefoxitin (2g IV after cord clamping) (n = 237) vs matching placebo (n = 238).

Outcomes

Febrile morbidity (oral temperature >38 degrees C twice 6 hours apart after first 24 hours); wound infection (wound cellulitis, erythema, discharge with or without fever); endometritis (fever, uterine tenderness, malodorous lochia); urinary tract infection (fever and positive urine culture); pneumonia; duration of hospital stay.

Notes

11% were HIV positive; Staphylococcus aureus most common pathogen (43%) isolated.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Allocation using random number table; not placebo controlled.

Participants

Women undergoing elective cesarean section or labour <12 hours.
Exclusion criteria: diagnosed amniotic infection; pyrexia >38 degrees C; antibiotics within 3 days; allergy to beta lactam antibiotics; cardiac disease; diabetes.
Setting: Sousse Hospital, Tunisia, February to July 1991.

Interventions

Cephapirine 1g IV with induction of anaesthesia and 6 hours after operation, gentamycin 80mg IM with induction, metronidazole 500mg IV with induction (n = 133), versus no treatment (n = 136).

Outcomes

Endometritis; wound infection; pyrexia only (>38 degrees C 48 hours after surgery): antibiotic 4/133 vs control 9/136; septicemia (0/133 vs 3/136, included as serious morbidity); duration of hospital stay (antibiotic 5.36 days vs control 6.21, p = 0.03, variance not given).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Allocated using last digit of patient's file number to treatment or no treatment.
No dropouts.

Participants

Women undergoing cesarean section due to acute fetal distress.
Setting: Bursa, Turkey.

Interventions

Ceftriaxone 1g (n = 25) vs mezlocillin 2g (n = 23) vs clindamycin 600mg and amikacin 500mg (n = 18) vs sulbactam ampicillin 1g (n = 25) intravenously after clamping of the cord vs no treatment (n = 28).

Outcomes

Wound infection (redness, tenderness, pain and purulent discharge); urinary tract infection (renal angle tenderness, fever, dysuria and pyuria); endometritis (vaginal spotting, purulent discharge with fever and pain) plus positive cultures.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate

Methods

Randomized (computer‐generated), partially double blind placebo‐controlled (3 groups: antibiotic irrigation, saline placebo irrigation, no irrigation). As the objective of this review is to compare antibiotic with no antibiotic, rather than the effect of irrigation, only the first 2 groups are compared (double blind comparison).

Participants

Both 'low risk' (labor < 6 hours) and 'high risk' (>6 hours) women undergoing cesarean section.
Exclusion criteria: allergy to penicillin or cephalosporin; antibiotic use within 7 days; antibiotics required for other reasons; pyrexia >38 degrees C; foul amniotic fluid.
Setting: Charlottesville, Virginia, USA, initiated March 1981; almost all were indigent women.

Interventions

Irrigation of the uterus and peritoneal cavity with 2g cefamandole in 1000ml normal saline (n = 73), versus saline placebo (n = 75).

Outcomes

Metritis (pyrexia >38 degrees C twice 8 hours apart, after 24 hours plus abnormal uterine tenderness, without another apparent source); duration of maternal stay (treatment 5.29 days vs placebo 6.32 days, variance could not be calculated).

Notes

Authors' definition of low and high risk do not correspond to those used for elective/non‐elective in this review.
No treated patients developed evidence of drug reaction.
There were no serious infections (pelvic abscess or phlebitis) in either group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomly allocated (abstract only; no further details).

Participants

Women undergoing high‐risk cesarean section.
Setting: Texas, USA.

Interventions

Cefazolin 2g in 1000ml irrigation (n = 20) vs normal saline 1000ml irrigation (n = 20).

Outcomes

Wound infection, endometritis, urinary tract infection.

Notes

Follow up 4‐6 weeks post‐operatively.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Double blind' randomized trial (the anaesthetist was not blind); list of random numbers consulted by nurse.

Participants

All women undergoing cesarean section.
Exclusion criteria: receiving antibiotics; pyrexia >37.4 degrees C; diagnosed infection; increased risk of infection, eg diabetes; known sensitivity to the antibiotics.
Mostly suburban or rural Chinese women of lower or middle class.
Setting: Prince of Wales Hospital, Hong Kong; October 1986 to February 1987.

Interventions

Intravenous therapy at time of induction of anaesthesia: ampicillin 1g (n = 96); ampicillin 1g and metronidazole 500mg (n = 104); ampicillin 1g and salbactam 500mg (n = 99), versus placebo (normal saline) (n = 101). Results of the three treatment groups combined.

Outcomes

Febrile morbidity (oral temperature of more than 38 degrees C at least twice after day 1); wound infection (induration, serosanguinous discharge or dehiscence with purulent discharge); urinary tract infection (positive culture); genital tract infection (pain and uterine tenderness, purulent uterine discharge with microbiological confirmation); any infection anywhere (antibiotic 75/299 vs placebo 28/101); post‐operative antibiotic use (22/299 vs 9/101).

Notes

Only moderate or prolonged febrile morbidity (as defined) included.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Double blind placebo controlled, computer generated sequence. Allocation to irrigation or intravenous route according to social security number.
Imbalance in randomized groups not accounted for (irrigation: cefoxitin 37 vs saline 23; overall 68 vs 56).

Participants

Women at increased risk of post‐cesarean section endometritis (in labor or with ruptured membranes). Classified as non‐elective for this review.
Exclusion criteria: allergy to penicillin or cephalosporins; antibiotic use within 48 hours; separate indication for use of antibiotics; temperature >38 degrees C; chorioamnionitis; pyuria.
Setting: Naval Hospital, San Diego, California; March to November 1982.

Interventions

Administration by irrigation of uterus and peritoneal cavity with 2g cefoxitin in 500ml saline (n = 37), versus 500ml normal saline (n = 23), or intravenously after clamping of the umbilical cord, cefoxitin 2g (n = 31) versus saline (n = 33). Irrigation and intravenous groups combined for this review.

Outcomes

Endometritis (febrile morbidity and uterine tenderness); total infection‐related morbidity (cefoxitin 10/68 vs saline 14/56); fever index; duration of intravenous antibiotics; additional antibiotics; days in hospital (no difference, variance not given).

Notes

One woman developed an allergic reaction to cefoxitin (acute pruritic rash).
There were two episodes of bacteremia (both in placebo groups); there were no episodes of septic pelvic thrombophlebitis nor drainage of pelvic abscess in either group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Allocated by sealed envelopes; not blinded or placebo controlled.

Participants

Women undergoing cesarean section; both elective and non‐elective deliveries.
Exclusion criteria: allergy to beta‐lactam antibiotics; pyrexia; indication for antibiotics.
Setting: Hopital Pellegrin, Bordeaux, France.

Interventions

Cefotetan 2g after clamping of umbilical cord (n = 55) versus no antibiotic (n = 55).

Outcomes

Endometritis; urinary infection; local complications; fever only (cefotetan 0/55 vs control 6/55); antibiotic therapy (10/55 vs 25/55); mean days in hospital (10.0 vs 10.2, no variance given).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomly assigned', no details given; not placebo‐controlled.

Participants

Women in labour with ruptured membranes requiring internal monitoring (non‐elective delivery).
Exclusion criteria: evidence of infection; penicillin or cephalosporin allergy.
Setting: Cleveland, Ohio, USA.

Interventions

Short course kefzol (1g intravenously 6 hourly for 24 hours, n = 24); long course (kefzol 1g intravenously for 8 or more doses and keflex 500mg orally 6 hourly for 5 days, n = 25); versus no prophylactic antibiotics. Short and long courses combined for this review.

Outcomes

Endometritis and/or wound infection (antibiotic 12/49 vs control 20/31).

Notes

It was possible to deduce the rate of endometritis alone, but not wound infection, for this review.
One late infectious complication (wound dehiscence) in control group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Double blind placebo controlled trial. Computer‐generated numbers using the mixed congruential method.

Participants

All women undergoing cesarean section.
Exclusion criteria: penicillin or cephalosporin allergy; antibiotic therapy; known infectious process.
Setting: Madigan Army Medical Centre, Tacoma, Washington, USA. December 1982 to May 1984.

Interventions

Irrigation during cesarean section with 2g of either cephapirin sodium (n = 79), cefamandole nafate (n = 70), moxalactam disodium (n = 64) or ampicillin sodium (n = 70), versus saline (n = 77). A vitamin was added to each solution for disguise. The antibiotic groups have been considered together in this review.

Outcomes

Fever (>38 degrees C twice 6 hours apart, excluding the first 24 hours); endomyometritis (pyrexia >37.8 degrees C, uterine tenderness and pelvic peritoneal irritation without other localising signs of irritation; urinary tract infection (positive culture); wound infection; fever index; all infection‐related morbidity; therapeutic antibiotics; mean postoperative days (variance not given).

Notes

Three episodes of pelvic thrombophlebitis (all in treated groups).
Results were given for all women and women in labour, both high risk (corresponding to the category of non‐elective deliveries) and all labour. The data for elective deliveries were deduced from these.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized, double blind, placebo‐controlled.
7/189 patients initially randomized were not included in analysis.

Participants

All patients undergoing cesarean section.
Exclusion criteria: clinical infection.
Setting: Chogoria Hospital, Kenya; December 1983 to June 1985.

Interventions

Metronidazole 1g rectal suppository 10‐45 minutes before and 8 hours after procedure (n = 91) versus placebo suppository (n = 91).

Outcomes

Fever (>37.9 degrees C on at least one occasion); wound infection; mean febrile days (0.56 for treatment vs 1.23 for control), hospital days, any antibiotic use (18/91 vs 23/91).

Notes

Elective cesarean section not defined.
No adverse events on mother or babies noted.
There was one grade 3 wound (defined as deep pelvic abscess or evidence of local or generalized peritonitis) in the treatment group as compared with three in the placebo group (classified as serious infectious morbidity).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Double‐blind, placebo‐controlled; numbered packages randomized by pharmacy; 9/110 'packages' not included (either damaged or patients failed to meet inclusion criteria); imbalance in group size (46‐placebo vs 55‐cefoxitin) not explained.

Participants

All women undergoing cesarean section (one third elective).
Exclusion: evidence of active infection, penicillin or cephalosporin allergy; recent antibiotic treatment.
Setting: Children's Hospital of Buffalo, USA; women enrolled between September 1979 and April 1980.

Interventions

Cefoxitin 2g IV (n = 46) versus saline placebo (n = 55) after clamping the umbilical cord and at 4 and 10 hours post‐operatively.

Outcomes

Febrile morbidity (temperature >38 degrees C twice 6 hours apart after first 24 hours); endometritis (fever, uterine tenderness, leukocytosis); wound infection (fever, cellulitis, exudate); maternal length of stay.

Notes

No serious life‐threatening infection in either group; no drug‐related side‐effects.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Double‐blind, randomized, prepared by hospital pharmacy; placebo‐controlled.
23/80 excluded because of errors in dispensation of medication.

Participants

All women undergoing either primary or repeat cesarean section (44% elective).
Exclusion: penicillin allergy; chorioamnionitis prior to surgery.
Setting: Walter Reed Army Medical Center, Washington DC; October 1976 and March 1977.

Interventions

Ampicillin 1g IV prior to surgery and 6 and 12 hours post‐operatively (n = 26) versus placebo (n = 31).

Outcomes

Febrile morbidity (>100.3 degrees fahrenheit twice 6 hours apart after first 24 hours); endomyometritis (fever, uterine and abdominal tenderness, purulent lochia); urinary tract infection (positive culture); wound infection (induration, erythema and warmth with purulent drainage); need for antibiotics (treatment 3/26 vs placebo 13/31); maternal hospital stay (6.03 vs 6.9; no variance given).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized in double‐blind fashion; placebo‐controlled.

Participants

Women undergoing cesarean section who were not in labor and did not have ruptured membranes (elective).
Setting: Washington, DC. US
From January 1970 to June 1980.

Interventions

Ampicillin 1g 30 min prior to surgery and at 4 and 8 hours post‐operatively (n = 42) versus placebo solution (n = 40).

Outcomes

Febrile morbidity (>100.4 degrees fahrenheit twice 6 hours apart after the first 24 hours); endomyometritis (fever, uterine and adnexal tenderness, purulent lochia); urinary tract infection; wound infection (induration, erythema and warmth with purulent drainage); need for antibiotics (treatment 1/42 vs placebo 6/40); maternal hospital stay (4.3 vs 4.6; no variance given).

Notes

No life‐threatening infection related complications nor bacteremic episodes in either group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized, using a table of random numbers; not placebo‐controlled. Allocated to either intravenous antibiotic, antibiotic irrigation, both routes or no treatment.

Participants

Women in active labor or ruptured membranes and at least one digital vaginal examination (categorized as non‐elective in this review although duration of membrane rupture not stated).
Exclusion: allergy to penicillin or cephalosporin, fever >37.7 degrees C with suspicion of chorioamnionitis; antibiotic use within two weeks.
Setting: Letterman Army Medical Center, California; Womack Army Community Hospital, North Carolina.

Interventions

Cefoxitin 2g IV after clamping the cord, repeated every six hours for 48 hours (n = 39) versus uterine and peritoneal lavage with 2g cefoxitin after delivery of the placenta (n = 42) versus irrigation plus intravenous therapy (n = 38) versus no therapy (n = 39). The three treatment groups have been combined in this review.

Outcomes

Febrile morbidity (>37.9 degrees C twice 6 hours apart after first 24 hours); endometritis (fever and uterine tenderness); urinary tract infection (positive culture); wound infection (including fever, cellulitis and exudate); hospital stay (treatment 4.86 vs control 5.2; variance could not be calculated).

Notes

3 episodes of septicemia reported in control group vs none in treatment groups.
No antibiotic reactions reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Assigned at random to either a control group or the study group by computer‐generated list of random numbers; not placebo‐controlled.

Participants

Women undergoing cesarean section. Exclusion criteria: severe penicillin allergy, renal insufficiency, antibiotic use, amniotic infection.
Setting: Nordwest Hospital, Frankfurt, West Germany.

Interventions

Mezlocillin 4g and oxacillin 2g every 8 hours after clamping of the cord for three doses (n = 50) vs no treatment (n = 50).

Outcomes

Endometritis, urinary tract infections, wound infections.

Notes

Detailed pre‐ and post‐ antibiotic microbiological cultures were performed; there were fewer gram positive cocci and more gram negative rods in cervical cultures of the treated group; more break‐through infections in the treated group were with mezlocillin‐resistant organisms.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Double blind, randomized by computerized tables; matching placebo doses; 3 patients excluded for inadequate follow‐up (group allocation not provided).

Participants

Women undergoing cesarean section (labor <12 hours, membrane rupture <12 hours, <7 vaginal exams).
Exclusion: any antibiotic within 2 weeks, fever, clinical evidence of infection.
Setting: Mexico.

Interventions

Ampicillin 1g intravenously every six hours x 3 then 1g every 6 hours x 7 days (n = 23) vs ampicillin 1g every 6 hours x 3 doses then placebo (n = 37) vs placebo (n = 31).

Outcomes

Fever >38 degrees C x 2 at least 6 hours apart after first 24 hours; endometritis (temperature >38 degrees C, purulent lochia, pain on internal examination); wound infection (increased warmth, size or colour of wound, or purulent secretions); urine infection (dysuria and positive culture).

Notes

No explanation provided for unequal size groups.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized (number allocated randomly to each of 90 boxes) placebo‐controlled (coloured vitamin added to placebo solution), double blind.

Participants

Women undergoing non‐elective cesarean section.
Exclusion: not in labour with intact membranes, allergy to cephalosporins, antibiotic use within 48 hours, fever, ruptured membranes for >36 hours.
Setting: Hopital Saint‐Luc, Montreal, Canada; September 1980 to November 1981.

Interventions

Cefoxitin 2g IV (n = 30) versus cefazolin 1g IV (n = 30) versus placebo (n = 30) at clamping of the cord and at 6 and 12 hours later. Both treatment groups have been combined.

Outcomes

Endometritis, wound infection, urinary tract infection (symptoms or two successive positive cultures) septicemia, pelvic abscess, pelvic thrombophlebitis. Follow‐up at 6 weeks. No side effects observed.

Notes

There were no serious infections in any of the groups.
In the placebo and cefazolin groups there was no increase in aerobic bacterial colonization of the cervix after 4 days but there was an increase in colonization by anaerobes; the opposite occurred in the group receiving cefoxitin.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized, double‐blind, placebo‐controlled.

Participants

All women undergoing either a repeat cesarean section or in labor.
Exclusion: clinical infection, ruptured membranes for >12 hours, prior antibiotics within 48 hours, renal or hepatic disease.
Setting: North Carolina, US.

Interventions

Cefazolin 1g intramuscularly pre‐operatively and cephalothin 2g intravenously at 6, 12, and 24 hours after first dose (n = 46) versus placebo (n = 49).

Outcomes

Wound infection (cellulitis, purulent exudate, intraperitoneal abscess or peritonitis); endometritis; urinary tract infection; maternal hospital stay.

Notes

No minor side‐effects (rash or pruritus) or major reactions (anaphylaxis) observed.
4 patients (all in control group) had septicemia [counted as serious morbidity].

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomly divided'; no further details; placebo‐controlled.

Participants

Women < 21 years old undergoing cesarean section.
Exclusion: antibiotic use within 2 weeks; active infection or fever at delivery; penicillin or sulfa allergy; internal fetal monitoring.
Setting: University Hospital, New Jersey; November 1983 and December 1984; lower socioeconomic class (90% black).

Interventions

Trimethoprim 240mg and sulfamethoxazole 1200mg intravenously after clamping of cord (n = 29) versus placebo (n = 28).

Outcomes

Endomyometritis (fever [>100.3 degrees fahrenheit twice within 24 hours after first day], uterine tenderness, absence of another focus); urinary tract infection (fever and positive culture); wound infection (fever, abnormal appearing wound with cellulitis or a wound draining purulent material).

Notes

Authors' definition of high risk not comparable with that used in this review.
The incidence of urinary tract infection and wound infection was similar between the groups (numbers not given).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Women randomized (no further details provided in translation); not placebo‐controlled.

Participants

Women undergoing cesarean section.
Setting: Universitats‐Frauenklinik Wien, Austria; August 1979 and April 1980.

Interventions

Metronidazole (n = 53) versus no treatment (n = 50).

Outcomes

Fever (>38 degrees C on two subsequent days); wound infection; endometritis; additional use of antibiotics (treatment 13/53 vs control 22/50); maternal hospital days.

Notes

Full translation pending.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Random allocation is presumed although method not described; placebo‐controlled; antibiotics prepared in coded identical vials by pharmacy; 17 patients initially randomized not included in outcome (? all in the treatment group).

Participants

Women undergoing primary cesarean section or repeat section.
Exclusion: penicillin allergy, fever in labor.
Setting: University of Pennsylvania; November 1971 and April 1972.

Interventions

Ampicillin 1g, methicillin 1g and kanamycin 0.5g intramuscularly 15 ‐ 30 minutes before, and at 2 and 8 hours after delivery (n = 33) versus placebo (n = 28).

Outcomes

Endometritis (fever and uterine tenderness or fever and pathogenic organism without other cause); urinary tract infection; wound infection (fever, cellulitis and exudate); morbidity [fever >100 degrees fahrenheit in two separate 24 hour periods after first post‐partum day or positive post‐operative urine culture of >100,000 colonies/ml] (treatment 9/33 vs placebo 17/28); maternal hospital stay (6.5 vs 6.9 days; no variance given).

Notes

Two serious infections: one pelvic abscess in treatment group, one septicemia in placebo group.
Authors' definitions of repeat and primary section not comparable to those used for elective/non‐elective in this review.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized (although method not described); placebo‐controlled; antibiotics prepared in coded identical vials by pharmacy.

Participants

Women undergoing primary cesarean section or repeat section.
Exclusion: penicillin allergy, fever in labor, errors in giving medication.
Setting: University of Pennsylvania; August 1972 and February 1973.

Interventions

Ampicillin 1g and kanamycin 0.5g intramuscularly 15 to 30 minutes before, and at 2 and 8 hours after delivery (n = 34) versus placebo (n = 34).

Outcomes

Endometritis (fever and uterine tenderness or fever and pathogenic organism without other cause); urinary tract infection; wound infection (fever, cellulitis and exudate; any grade); morbidity [fever >100 degrees fahrenheit in two separate 24 hour periods after first post‐partum day or positive post‐operative urine culture of >100,000 colonies/ml] (treatment 8/34 vs placebo 22/34).

Notes

One pelvic abscess in placebo group.
Authors' definitions of repeat and primary section not comparable to those used for elective/non‐elective in this review, categorized as 'both'.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomized, double‐blind', details not specified; placebo‐controlled.

Participants

Women in labor with rupture of membranes (non‐elective).
Exclusion: infection, antibiotics within prior 3 days, allergy to penicillin or cephalosporin; no consent.
Setting: Robert B Green Memorial Hospital, Texas, US; October 1978 and July 1979; patients indigent and predominantly Mexican‐American.

Interventions

Cefamandole 2 g IV after cord clamping, and at 4 and 8 hours post‐operatively (n = 50) versus identical appearing placebo (n = 50).

Outcomes

Endomyo(para)metritis; wound infection; maternal hospital stay; records reviewed 6 weeks to 6 months after discharge. Four episodes of bacteremia (1 in treatment group, 3 in placebo) have been categorized as serious outcomes.

Notes

No incidence of pelvic abscess or septic thrombophlebitis in either group.
Increase in Enterobacteriacae and enterococci and decrease in gram positive anaerobes and nonpathogens in prophylactic group.
No adverse clinical or laboratory results attributable to treatment.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'At random'; not placebo‐controlled, not double‐blind; investigator not intimately involved with post‐operative care.

Participants

Women undergoing cesarean section.
Exclusion: emergency section, penicillin allergy, fever >38 degrees C, on antibiotics; declined to participate.
Setting: San Bernadino county and University of California at Los Angeles Medical Centers; primarily indigent cases; enrolment started November 1976.

Interventions

Ampicillin 1g IV 15‐30 minutes before surgery and at 2 and 8 hours post‐operatively (n = 38) versus ampicillin 1g IV immediately after cord clamping and at 2 and 8 hours post‐operatively (n = 40) versus no antibiotic (n = 36); results for both treatment groups combined.

Outcomes

Endometritis; wound infection; urinary tract infection; maternal hospital stay (5.1 and 4.7 for pre‐ and post‐ administration of antibiotics respectively vs 6.0 for no treatment, variance not given).

Notes

Although emergency cesarean sections were excluded, the women enrolled did not conform to our definition of an elective section.
Information on neonatal morbidity collected; there were two infants with definite infections in mothers who received no antibiotics and one infection in an infant where antibiotics were given after cord clamping.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomly divided' (no details provided); placebo‐controlled.

Participants

Women undergoing cesarean section; elective cesarean sections not included but definition not provided.
Exclusion: antibiotics prior to procedure.
Setting: School of Midwifery, Helsinki, Finland.
Patients enrolled from December 1981 to August 1982.

Interventions

Metronidazole 500mg intravenously after cutting of cord (n = 109) vs placebo (n = 110).

Outcomes

Wound infection, endometritis.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized, double‐blind manner, according to prenumbered envelopes maintained in the central pharmacy; placebo‐controlled.

Participants

Women undergoing primary, nonelective cesarean section (while it appears most women were in labour and/or had ruptured membranes it is unclear whether all patients fulfilled our criteria for non‐elective).
Exclusion: antibiotic use within 7 days, penicillin or cephalosporin allergy.
Setting: Central Baptist Hospital, Lexington, Kentucky, US.

Interventions

Cefamandole 500mg IV immediately after the cord was clamped, again in the recovery room and two more doses 6 hours apart (n = 43) versus identical‐appearing placebo (n = 47).

Outcomes

Infectious morbidity (fever >100.3 degrees fahrenheit twice 6 hours apart after first 24 hours); endomyometritis (fever, uterine tenderness, and positive culture from endometrium); wound infection, urinary tract infection; maternal duration of stay (treatment 5.1 days vs placebo 5.4; not significant, no variance given).

Notes

There was one episode of bacteremia in the control group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Double‐blind, randomized (method not described); placebo‐controlled.

Participants

Women undergoing emergency cesarean section (during labor and/or after rupture of membranes).
Exclusion: fever >38 degrees C, given antibiotics, chemotherapy or immunosuppressive therapy in prior 3 weeks, allergy to cephalosporins, alcohol or drug abuse, chronic disease of cardiovascular, renal, hepatic or gastrointestinal system, severe anemia.
Setting: University Hospital, Lund Sweden, July 1983 and December 1986.

Interventions

Cefuroxime 1.5g IV at the start of the operation and 12 hours later (n = 80) versus saline placebo (n = 80).

Outcomes

Endometritis (fever >38 degrees C twice at least 1 hour apart, after the first post‐operative day, and increased tenderness of the uterus); wound infection (redness, tenderness, increased heat and edema of wound); urinary tract infection.

Notes

There were no cases of septicemia or abscess formation observed in either group.
Only 55% of women had ruptured membranes (number >6 hours not stated) and 77% were in labor; these definitions do not meet our criteria for non‐elective section, categorized as 'both'.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized, double‐blind, placebo‐controlled; 'according to a random schedule'.
10/396 women initially randomized not included in final analysis (errors in protocol, two allergic to penicillin after first dose given and 2, who received cefoxitin, for infusion‐related reactions); insufficient data provided to perform intent to treat analysis.

Participants

Women undergoing cesarean section after labor or rupture of membranes (method section unclear as to duration of ruptured membranes; it has been assumed that all women were in labor).
Exclusion: elective cesarean section without labor; already receiving antibiotics; fever or other evidence of infection; allergy to penicillin or cephalosporins; requiring endocarditis prophylaxis.
Setting: Pittsburgh, Pennsylvania, US.

Interventions

Cefoxitin 2g intravenously after cord clamping, and at 6 and 12 hours after initial dose (n = 196) versus matching mannitol and riboflavin placebo (n = 196).

Outcomes

Febrile morbidity (fever >37.9 degrees C twice at least 4 hours apart after first post‐operative day); endomyometritis (fever >38 degrees C with uterine tenderness, maternal white blood cell count >15000/cu mm, malodorous lochia and no apparent cause for fever); urinary tract infection; incision infection (purulent drainage with induration and tenderness); additional antibiotic therapy (treatment 26/196 vs placebo 68/190).

Notes

Increase in enterococci and decrease in Staphylococcus aureus, various streptococci, E. coli and a variety of anaerobes from infected sites in prophylactic group compared with placebo.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized, double‐blinded, placebo‐controlled.
7 patients initially randomized excluded from analysis: 1 because of an error in drug administration and six because they became febrile and were treated within 8 hours of operation; insufficient data provided to perform intent‐to‐treat analysis.

Participants

Women undergoing cesarean section (at 'high' risk because of ruptured membranes in active labor); classified as 'non‐elective'.
Exclusion: febrile, antibiotic use in prior 24 hours; allergy to penicillin or cephalosporin; significant hepatic or renal disease.
Setting: Mount Sinai Hospital, Toronto, Canada, July 1980‐June 1981.
Predominantly private, middle‐class and in their late 20s.

Interventions

Cefoxitin 2g intravenously at time of cord clamping (n = 64) versus cefoxitin 2g at time of cord clamping and at 4 and 8 hours post‐operatively (n = 60) versus identical‐appearing placebo; both treatment groups combined in this analysis.

Outcomes

Febrile morbidity (>38 degrees C twice at least 8 hours apart, after first post‐operative day); endometritis (fever, foul, excessive lochia or uterine tenderness); urinary tract infection (fever and positive culture); wound infection (fever, cellulitis or exudate with positive cultures).

Notes

No adverse drug reactions in cefoxitin groups, no septicemia in any group; four patients in placebo group were considered seriously ill (although do not fit the criteria for serious morbidity in this review) compared to none in treatment groups.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Double‐blind, randomized, placebo‐controlled.

Participants

Undergoing cesarean section.
Exclusion: preoperative fever, antibiotics within one week, membranes ruptured >36 hours, evidence of chorioamnionitis, penicillin or cephalosporin allergy.
Setting: University of Illinois College of Medicine, Chicago, US (large, inner city hospital); majority of subjects black (40%) or Hispanic (60%).

Interventions

Cefoxitin 2g after cord clamped and at 4 and 8 hours (n = 74) versus placebo (n = 78).

Outcomes

Endometritis (fever and uterine tenderness or fever and pathologic organism without other focus); wound infection (fever, cellulitis and exudate); urinary tract infection (fever and symptoms or positive culture).

Notes

In the placebo group there were 8 episodes of serious morbidity (6 cases of sepsis; one pelvic abscess; one episode of pelvic thrombophlebitis) compared with one in the treated group (one episode of sepsis).
Routine post‐operative cultures were performed: enterococci were isolated from 30/68 cases who received cefoxitin vs 15/74 who received placebo; there was no change in the rate of cefoxitin resistance in Enterobacteriaceae from the stool after prophylaxis.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomly assigned (method not stated); placebo controlled.
It is unclear whether all patients randomized were included in the analysis.

Participants

Women undergoing cesarean section.
Exclusion: women with active infection, allergy to penicillin and antibiotic treatment within 2 weeks.
Setting: Kfar‐Sava, Israel.

Interventions

Mezlocillin 5g intravenously during 30 minutes prior to surgery (n = 38) vs placebo (n = 40).

Outcomes

Febrile morbidity (>38 degrees C twice at least 4 hours apart after first 24 hours post‐operative); endometritis (fever and uterine tenderness); urinary tract infection (single culture of >100,000 bacteria/ml); wound infection (redness, cellulitis, tenderness and exudate from incision).

Notes

Authors' definition of emergency not consistent with definitions used in this review (classified as 'both/undefined').

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized by computer program to one of two groups at time of their first antenatal visit; not placebo‐controlled.
Imbalance in group size not accounted for.

Participants

Low risk women requiring cesarean delivery (elective procedure, duration of membrane rupture <3 hours, no more than two vaginal examinations).
Exclusion: required a drug other than cefazolin for prophylaxis, fever, membrane rupture >24 hours.
Setting: Rambam Medical Center, Haifa, Israel.

Interventions

Cefazolin 1g after clamping of the cord (n = 167) versus no treatment (n = 140).

Outcomes

Febrile morbidity (fever >37.7 degrees C twice at least 4 hours apart after first 24 hours); endometritis (fever, uterine tenderness and abnormal lochia); urinary tract infection (fever and positive culture); wound infection (fever, cellulitis or exudate with positive culture); therapeutic antibiotic use (treatment group 6.5% versus 20% in control group, p <0.001).

Notes

Although some women were in labour at the time of the procedure (mean duration of labour 53 and 44 minutes in the two groups), the study population so closely resembles the criteria for elective cesarean section used in this review that the results have been included in the 'elective' category.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomized according to a code'; placebo‐controlled. 8 women excluded: 4 because they were febrile before the operation, four because of mistakes in administration; data not provided to perform intent to treat analysis.

Participants

Initially all women undergoing cesarean section (n = 80); thereafter women undergoing non‐elective (ruptured membranes) section (n = 72).
Setting: South Saimaa Central Hospital, Lappeenranta, Finland, May 1982‐August 1983.

Interventions

Tinidazole 500mg IV at cord clamping (n = 75) versus identical placebo (n = 77).

Outcomes

Febrile morbidity (>38 degrees C on 2 postoperative days, excluding the first); endometritis (fever, foul lochia or uterine tenderness); wound infection (fever, cellulitis or exudate); urinary tract infection (fever and positive culture).

Notes

Authors' definition of non‐elective (ruptured membranes) and elective (unruptured membranes) not consistent with the definitions used in this review; classified in this review as 'both'.
Newborn infants observed for effects of tinidazole (although data not given).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized by last digit of hospital admission number to no irrigation, antibiotic irrigation or saline irrigation (placebo‐controlled). As the objective of this review is to compare antibiotic with no antibiotic, rather than the effect of irrigation, the two irrigation groups are compared.
Follow‐up given for only 77/84 of treatment and 53/86 of placebo group for outcome of serious infection, without explanation; intent to treat analysis has been performed.

Participants

Women undergoing nonelective cesarean section (including prolonged ruptured membranes and prolonged labor, as well as general risk factors such as poor nutrition and poverty).
Exclusion: current antibiotics, known infectious process, allergy to cephalosporins.
Setting: University of Mississippi Medical Center, September 1982‐September 1983.

Interventions

Cefamandole 2g in 800ml saline irrigation during the procedure (n = 84) versus saline irrigation (n = 86) versus no treatment (n = 92); only first two groups included.

Outcomes

Febrile morbidity (>100.6 degrees fahrenheit twice 6 hours apart after first post‐operative day); serious morbidity (fever and endomyometritis or abscess requiring IV antibiotics for resolution).

Notes

Authors' definition of high risk does not correspond to that used for non‐elective in this review, classified as 'both'.
The outcome of serious morbidity included endomyometritis and is classified as endometritis in this review.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate

Methods

'Random allocation', placebo controlled.
6 women initially randomized not included in analysis (non‐adherence or noninfectious complications).

Participants

All women undergoing cesarean section (51/97 not in labor; 61/97 without ruptured membranes).
Exclusion: signs of infection, allergy to penicillin or cephalosporin, antibiotics within 2 weeks; lack of consent.
Setting: Medical University Hospital of South Carolina; November 1975‐June 1976.

Interventions

Cefazolin 1g IV pre‐operatively and at 2 and 8 hours post‐operatively (n = 48) versus similar volume of placebo (n = 49).

Outcomes

Febrile morbidity (>100.3 degrees fahrenheit twice on any of first 10 post‐partum days after the first); endometritis (fever and uterine tenderness, or fever and pathogen from endometrium without other cause); urinary tract infection (fever or positive culture and symptoms); wound infection (fever, cellulitis and/or exudate).

Notes

Aerobic isolates unchanged, fewer anaerobes in patients given placebo; most pathogens isolated were resistant to cefazolin whether treatment or placebo given.
There were two episodes of septicemia (both in placebo group).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomly allocated' using envelope containing empty vial or vial containing treatment; not placebo‐controlled; women, attending physicians and study coordinators were 'blind'.

Participants

Women undergoing nonelective cesarean section (58/201 without labour; 65/201 without ruptured membranes).
Exclusion: fever, antibiotics within 7 days, penicillin or cephalosporin allergy.
Setting: Odense University Hospital, Denmark, February 1987‐March 1988.

Interventions

Cefuroxime 750mg IV after cord clamping (n = 102) versus no treatment (n = 99).

Outcomes

Febrile morbidity (>37.9 degrees C twice at least 6 hours apart after first post‐operative day); endometritis (fever, uterine tenderness and abnormal lochia); wound infection (fever, cellulitis and/or purulent discharge); urinary tract infection; cost of post‐operative antibiotics (treatment $US0.69 vs control $US7.47); maternal hospital stay (treatment 8.1 vs control 8.0, no variance given).

Notes

No woman had a severe infection such as pelvic abscess or septic pelvic thrombophlebitis.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Double blind, placebo controlled.

Participants

Women undergoing elective or non‐elective cesarean section. Age range 17‐40 years.
Exclusion criteria: allergy to metronidazole, amnionitis, and pyrexia.
Setting: Athens, Greece.

Interventions

Metronidazole 500mg intravenously 2 hours or immediately preoperatively, 500 mg intraoperatively, 1000mg 8 hours postoperatively (n = 50), versus placebo (n = 50).

Outcomes

Wound infection; endometritis; inadequate wound healing (metronidazole 1/50 vs placebo 8/50); mean temperature (36.8 degrees C SD 1.02 vs 37.6, 1.03); duration of hospital stay.

Notes

Language: Bulgarian.
Although the authors are not identical and the presentation of the data makes direct comparisons difficult, the description of the two studies cited is so similar that it is presumed the two citations refer to the same patient population.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomly divided'; blinded, placebo‐controlled.

Participants

Women undergoing primary cesarean section after onset of labour (corresponds to the definition of non‐elective).
Exclusion: febrile or infected, allergy to pipericillin.
Setting: Jersey City Medical Center, New Jersey; predominantly lower socio‐economic indigent women.

Interventions

Pipericillin 4g peri‐operatively (n = 50) versus pipericillin 4g peri‐operatively and at 4 and 8 hours post‐operatively (n = 50) versus placebo (n = 50); both treatment groups combined in analysis.

Outcomes

Febrile morbidity (> 38.0 degrees C twice at least 6 hours apart after first post‐operative day); endometritis (fever, tender uterus and purulent lochia); hospital stay (no significant difference, variance not given).

Notes

Use of saline or antibiotic lavage not allowed
No adverse reactions reported with treatment.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized (using lottery method), double‐blind, placebo‐controlled; four women excluded because of protocol deviations.

Participants

All women undergoing cesarean section (39/128 repeat section).
Exclusion: fever or infection, allergy to antibiotics.
Setting: Kaiser‐Permanente Medical Center‐Santa Clara, California; February‐June 1982.

Interventions

Cefoxitin 2g in 1L saline irrigation (n = 41) versus cephapirin 2g in 1L saline irrigation (n = 44) versus identical appearing placebo saline irrigation (n = 43) after delivery of the placenta; both treatment groups combined in the analysis.

Outcomes

Urinary tract infection (positive culture); wound infection (purulent wound discharge with or without wound separation); endometritis (fever >100.4 degrees fahrenheit after first post‐operative day, uterine tenderness, foul smelling lochia without other source).

Notes

Follow‐up for 8 weeks.
One patient in placebo group developed septic pelvic thrombophlebitis and septic pulmonary emboli, classified as a serious complication.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Random, double‐blind, placebo‐controlled; results on 15/227 women initially randomized not included in analysis.

Participants

Women undergoing elective and nonelective cesarean section.
Exclusion: antibiotic use within 2 weeks, allergy to penicillin.
Setting: Louisiana State University Hospital; 90% indigent population, July 1985‐January 1986.

Interventions

Ticarcillin 5g in 1200ml saline irrigation (n = 112) versus saline irrigation (n = 100).

Outcomes

Febrile morbidity (>100.3 degrees fahrenheit twice at least 4 hours apart after first post‐operative day); endomyometritis, wound infection, urinary tract infection, septicemia, maternal hospital stay (treatment 4.5 vs placebo 5.4, no variance given).

Notes

Definition of elective and nonelective cesarean section not provided.
There were 3 episodes of septicemia in those women undergoing emergency section (2 in the control group and one in the placebo group).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomly allocated (using randomized list of treatment numbers), double‐blind, placebo‐controlled.

Participants

All women undergoing elective cesarean section (before onset of labour or rupture of membranes; corresponds to our definition of elective).
Setting: University of Zimbabwe; patients enrolled between November 1986 and March 1987.

Interventions

Crystalline penicillin 2MU and chloramphenicol 500mg pre‐operatively ( n = 115) versus matching placebo (n = 117).

Outcomes

Fever (>37.9 degrees C twice at least 4 hours apart after first post‐operative day); wound sepsis (graded as abnormal erythema and/or induration, oozing wound without frank pus or pus formation); endomyometritis (fever, uterine tenderness and foul‐smelling lochia), pelvic abscess formation, bacteremia; maternal hospital stay (treatment 5.43 vs placebo 6.18, variance not given).

Notes

No woman developed pelvic abscess nor required a laparotomy.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized trial 'by drawing of lots', placebo‐controlled.

Participants

'Low risk' women, undergoing cesarean section (27% in labour). Exclusion: allergy to beta‐lactam antibiotics, receipt of antibiotics within 3 days; ruptured membranes >12 hours; fever, amniotic infection.
Setting: Grenoble, France, July 1986‐December 1987.

Interventions

Cefotetan 1g IV at the time of cord clamping (n = 136) versus placebo injection (n = 130).

Outcomes

Endometritis, wound infection, septicemia; additional antibiotic use (10/136 in treatment group vs 19/130 in placebo); antibiotic costs; maternal hospital stay.

Notes

There was one episode of septicemia in the placebo group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized, double‐blind, placebo‐controlled.

Participants

All women undergoing cesarean section (8/73 were repeat).
Exclusion: already on antibiotics.
Setting: National Women's Hospital, Auckland, New Zealand; June ‐ September 1979.

Interventions

Metronidazole 500mg IV prior to incision and metronidazole 2g suppository at end of surgery (n = 35) versus matching placebo infusion and suppository (n = 38).

Outcomes

Fever (>37.9 degrees C within 14 days of delivery); wound infection, endometritis, urinary tract infection, major complication (return to theatre or hospitalized >10 days because of post‐operative morbidity); need for antibiotic therapy (treatment 13 vs placebo 10); fever index (257 degree hours vs 165 hours).

Notes

One major complication (not infectious) in each group (bleeding from lower segment in one, major deep vein thrombosis extending into iliac veins in another).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'On a random basis'; partly placebo‐controlled.

Participants

All patients undergoing cesarean section.
Women with pre‐existing urinary tract infection were excluded.
Setting: Durban, South Africa.

Interventions

Ampicillin 500mg IM pre‐operatively and 8 hourly for 48 hours followed by 500mg orally 8 hourly for 4 days (n = 150) versus no treatment for first 48 hours then oral placebo 8 hourly for 4 days (n = 150).

Outcomes

Urinary tract infection (culture positive), intra‐uterine infection not defined further, classified as endometritis), wound infection.

Notes

Fewer post‐partum urinary isolates in treated group were sensitive to ampicillin (8/17 vs 18/26).
In the control group, three women developed pelvic abscesses (included as serious morbidity) and one patient required hysterectomy for secondary postpartum haemorrhage following severe E. coli intra‐uterine infection.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized, double‐blind, placebo‐controlled (using unmarked code‐numbered separate boxes).

Participants

Women undergoing emergency cesarean section (ruptured membranes for >6 hours and <20 hours; corresponds to our definition of non‐elective).
Exclusion: prior antibiotic therapy, fever >37.2 degrees C, fetal tachycardia of >160/minute.
Setting: University of Natal, Durban, South Africa.

Interventions

Lincomycin 600mg (n = 20) versus metronidazole 500mg (n = 20) versus placebo (n = 20) intravenously 2 hours pre‐operatively and 8 hourly for 48 hours; both treatment groups are combined for the analysis.

Outcomes

Wound discharge/abscess formation, puerperal sepsis (>37.9 degrees C twice in first 48 hours or >37.5 degrees C from 2nd post‐operative day), septicemia, urinary tract infection.

Notes

Authors' definition of puerperal sepsis has been classified as fever.
No complications of drug administration reported in mothers or babies; no rash, diarrhoea nor nausea.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized (code generated by pharmacy), double‐blind, placebo‐controlled; code broken when fever developed
14/162 excluded for protocol violations.

Participants

All women undergoing cesarean section (49/148 were repeat procedure; 57/148 were not in labour).
Exclusion: membranes ruptured >24 hours.
Setting: Norfold General Hospital, Virginia; both private (n = 70) and clinic (n = 78) women included.

Interventions

Cephalothin 2g IV 15‐30 minutes prior to surgery and 1g every 6 hours for 36 hours, then cephalexin 500mg orally every 6 hours until 5th post‐operative day (n = 74) versus identical appearing placebo (n = 74).

Outcomes

Fever (>100.3 degrees fahrenheit twice after 48 hours); endometritis (fever, uterine tenderness, foul‐smelling or abnormal lochia and positive cultures); urinary tract infection, wound infection; maternal hospital stay (treatment 6.2 vs placebo 7.5, no variance given).

Notes

All bacterial isolates in treatment group were sensitive to cephalothin.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Alternate allocation to treatment or no treatment; not placebo‐controlled.

Participants

All women undergoing cesarean section.
Exclusion: febrile or infected.
Setting: City of Memphis Hospitals, Tennessee; indigent women, many obstetric and metabolic complications.

Interventions

Aqueous penicillin 10 MU every 8 hours and kanamycin 500mg IM every 12 hours pre‐operatively and for 3 days post‐operatively (n = 115) versus no treatment (n = 115).

Outcomes

Fever (>100.9 degrees fahrenheit after first post‐operative day), severe pelvic infection (treatment 27% vs control 7%); 'free of infectious morbidity' (3.6 vs 6.8 days); maternal hospital stay (5.4 vs 8.8 days, no variance given).

Notes

No adverse drug reactions reported; no evidence of development of resistance reported.
Unable to ascertain from description of study incidence of endometritis or wound infection; inadequate description of nature of severe pelvic infections (not included as outcome in analysis).
Two groups of women were studied retrospectively (n = 75); methods nor results do not specifically describe results of this group and it is unclear whether they have been included in the overall results.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate

Methods

Randomized to treatment or no treatment (method not described). Two patients excluded (one from cefoperazone group, one from no treatment group); intent to treat analysis performed.

Participants

Women undergoing cesarean section.
Exclusions: hypersensitivity to one of antibiotics; presence of infection or fever; on antibiotics; multiple pregnancy.
Setting: Ipoh, Malaysia.

Interventions

Cefoperazone 1g every 12 hours x 3 (n = 71) vs ampicillin 500mg every 6 hours x 4 (n = 74) vs no treatment (n = 77); both treatment groups combined for data analysis.

Outcomes

Wound infection (inflammation over wound with serous or purulent discharge); any antibiotics post‐operatively (cefoperazone vs ampicillin vs no treatment: 6.6% vs 16.2% vs 25.7%). Hospital stay: ampicillin vs no treatment 5.57 days (SD 1.43) vs 6.5 days (SD 3.67).

Notes

Author's definition of emergency not consistent with criteria used in this review; classified as both/undefined.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomly assigned, double‐blind, placebo‐controlled; medication code kept in pharmacy.

Participants

All women undergoing cesarean section (35/71 were a repeat section). The authors definition of primary and repeat are different from those used in this review and have not been analysed separately; most women for repeat section were in early labour at the time the operation was performed.
Exclusion: fever, membrane rupture >24 hours, penicillin allergy, lack of consent.
Setting: Johns Hopkins Hospital, Baltimore.

Interventions

Ampicillin 2g pre‐operatively (n = 34) versus similar‐appearing placebo (n = 37).

Outcomes

Fever (>37.0 degrees C twice at least six hours apart after first post‐operative day); endometritis, urinary tract infection, wound infection, bacteremia, pelvic abscess, maternal hospital stay.

Notes

There was one pelvic abscess in the placebo group; there were 3 episodes of bacteremia (1 Klebsiella spp. in treatment group, 2 group B streptococcal infections in placebo); combined for outcome of serious morbidity.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomly assigned, case number known only by pharmacy; placebo‐controlled.
8 women excluded for mistakes in protocol.

Participants

All women undergoing cesarean section (46/122 were a repeat section). The authors' definition of primary and repeat do not correspond to definitions of elective and nonelective used in this review (repeat sections included women in labor with ruptured membranes). The results for these two categories have been combined in this review.
Exclusion: allergy to penicillin or cephalosporin, infection or receiving antibiotics.
Setting: Naval Regional Medical Center, Portmouth, Virginia, US, July‐December 1976.

Interventions

Cefazolin 500mg IV 30 minutes before and 500mg at 2 and 1g at 8 hours after delivery (n = 61) versus matching placebo (n = 61).

Outcomes

Endometritis (fever and uterine tenderness or fever and pathogenic organism); urinary tract infection (fever and symptoms, or positive culture); wound infection (fever, cellulitis and exudate); maternal hospital stay (treatment 5.5 days versus placebo 5.7 days, no variance given).

Notes

Two women developed serious complications as stated by the authors: one in treatment group developed septic pelvic thrombophlebitis; one given placebo developed pneumonia and endoparametritis (both included in outcome of serious morbidity).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

'Randomly allocated'; double blind; placebo‐controlled.
12 participants withdrawn (8 treatment, 4 placebo); intent to treat analysis performed.

Participants

All women undergoing cesarean section (other than repeat section); criteria do not correspond with our definition of non‐elective.
Exclusion: active infection, fever, membranes ruptured >36 hours, antibiotic therapy within 2 weeks, renal disease, allergy to penicillin or cephalosporin.
Setting: Brigham and Women's Hospital, Boston, Massachusetts, US, July 1978‐October 1980.

Interventions

Cefazolin 2g after cord clamped (n = 146) and at 4 and 8 hours after first dose versus matching placebo (n = 132).

Outcomes

Fever (oral temperature >100.3 degrees fahrenheit on any of 2 of first 10 postoperative days); urinary tract infection, wound infection (only pus‐draining included in outcome of wound infection); endometritis (fever, tenderness on pelvic examination, abnormal discharge); pelvic abscess; septic pelvic thrombophlebitis, bacteremia; subsequent antibiotic use (23% for placebo vs 12% for treatment).

Notes

Outcome of fever and minor wound infection combined (11/146 for treatment vs 13/132 for placebo).
Four episodes of bacteremia, all in placebo group.
One episode of rash and one episode of phlebitis reported in treatment group vs none in control.
Data collected at 6 weeks on 259/266 patients; 35% of infections diagnosed after discharge.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized to treatment or no treatment. One drop‐out (no treatment) included in intent to treat analysis.

Participants

Women undergoing cesarean section.
Setting: Hanover, Germany.

Interventions

Mezlocillin 2g intravenously half hour pre‐operatively then every eight hours x 4 (n = 70) vs no treatment (n = 70).

Outcomes

Wound infection (inflammation with or without exudation); endometritis (fever and tenderness of the uterus or fever with pathogens from the cervical canal); urinary tract infection (>100,000 bacteria/ml).

Notes

One episode of allergic skin reaction occurred with the injection of mezlocillin.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Assigned at random' to one of three regimens; code kept secret; placebo‐controlled; data from a fourth group that consisted of patients allergic to one of the drugs or undergoing an emergency section have not been included.
Two women excluded after initial randomization.

Participants

All women undergoing cesarean section.
Exclusion: allergic to penicillin, clindamycin or gentamicin; emergency section.
Setting: State Maternity Hospital, Helsinki, Finland, September 1977‐January 1978.

Interventions

10 million units benzyl penicillin IV (n = 46) versus 500mg clindamycin IV and 80 mg gentamicin IM (n = 42) versus glucose solution placebo (n = 40) IV by infusion starting 30 minutes before operation and stopping 4 hours after. Results of both treatment groups combined.

Outcomes

Endometritis (fever, uterine tenderness and foul‐smelling vaginal discharge); wound infection (all grades combined); hospital stay (treatment 7.7 vs 7.7 placebo; no variance given).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized using computer‐generated number screen; not placebo controlled, but patient and study co‐ordinators unaware of group allocation.

Participants

Women undergoing elective cesarean section (absence of labor and before rupture of membranes).
Exclusion: allergy to penicillin or cephalosporin, prior antibiotic therapy within 7 days.
Setting: United Arab Emirates.

Interventions

Cefuroxime 1.5g after clamping of the cord vs no treatment.

Outcomes

Febrile morbidity (temperature of >38 degrees C after first 48 hours); endometritis (uterine tenderness and offensive lochia with fever and no other source); wound infection (erythema, induration or purulent discharge); urinary tract infection (>100,000 bacteria/ml).

Notes

Majority of patients were indigent; follow‐up at 6 weeks.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

'Randomly allocated'; placebo‐controlled.
8 women excluded because of protocol failures and 9 women for intraoperative complications (not defined further).

Participants

All women undergoing cesarean section (77/129 were elective sections).
Exclusion: active infection, antibiotics within 7 days, allergy to penicillin or cephalosporin, impaired liver or renal function.
Setting: Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, The Netherlands, April 1983‐October 1984.

Interventions

Cefoxitin 2g (n = 64) versus matching placebo (n = 65) IV bolus immediately following clamping of the cord and at 6 and 12 hours later.

Outcomes

Febrile morbidity (>38 degrees C for at least 24 hr after first 24 hr); endometritis (fever, fetid lochia and/or uterine tenderness on pelvic examination); wound infection (palpable induration, wound dehiscence and/or pus drained); urinary tract infection (positive culture), bacteremia.

Notes

One episode of Staphylococcus aureus bacteremia (in cefoxitin group) not considered life‐threatening (included in outcome of serious morbidity). No serious antibiotic side‐effects reported in cefoxitin‐treated group; one patient in cefoxitin group developed diarrhoea.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomized, sequential basis'; placebo controlled.

Participants

Women undergoing emergency cesarean section (in active labour with membrane rupture).
Exclusion: pyrexia; antibiotic use within 2 weeks.
Setting: Addenbrooke's Hospital, Cambridge, UK.

Interventions

Metronidazole 500mg (n = 57) versus placebo (n = 58) IV infusion at start of procedure; postoperatively metronidazole or placebo suppository twice daily for 5 days.

Outcomes

Pyrexia (>38 degrees C twice 4 hours apart after first 24 hours); wound infection; endometritis (heavy, offensive lochia and pyrexia); urinary tract infection; antibiotic use (15/57 in treatment group vs 20/58 in control group).

Notes

One woman in the control group developed a pelvic abscess.
Length of admission not significantly different between the two groups (mean 7.4, sd 2.3 days).
No adverse reactions occurred.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized using last digit of hospital chart: even to treatment, odd to no treatment (not placebo‐controlled).

Participants

All women undergoing cesarean section (divided into "no labour" and "labor" groups which correspond to the definitions of elective/non‐elective used in this review.
Exclusion: fever, antibiotic use within 2 weeks, ruptured membranes >2 hours, major penicillin allergy.
Setting: New York Medical College, New York, US.

Interventions

Cephalothin 2g IV and kanamycin 1g IM at induction of anesthesia, then cephalothin 2g IV q6hrs x 8 doses and kanamycin 500mg IM q12hr x 4 doses (n = 47) versus no treatment (n = 53).

Outcomes

Endometritis (fever, uterine tenderness and positive culture or fever and pathogenic organism); urinary tract infection, wound infection (fever and cellulitis or exudate).
Data available on elective (defined as no labor) and non‐elective (defined as presence of labour).

Notes

No difference in average duration of hospital stay between groups (data not shown).
One woman (treatment group) developed endometritis with organism resistant to cephalothin and kanamycin.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate

Methods

Randomized using computer‐generated code, kept confidential, to treatment or identical placebo.

Participants

Women undergoing cesarean section (both elective and emergency).
Exclusions: use of antibiotics, fever or signs of infection; allergy to penicillin or cephalosporin.
Setting: Jeddah, Saudi Arabia.

Interventions

Cefazolin 1g after clamping of the cord (n = 221) vs matching placebo (n = 220).

Outcomes

Febrile morbidity (>38 degrees C twice 4 hours apart after first 24 hours); endometritis (fever, uterine tenderness and abnormal lochia); wound infection (fever, cellulitis or exudate with positive culture); urinary tract infection (fever and positive urine culture); pneumonia, bacteremia, pelvic abscess, unexplained fever, therapeutic antibiotics, length of post‐operative stay.

Notes

Emergency cesarean section not defined, results reported in undefined category.
Fetal outcomes reported; no serious side effects with cefazolin.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomly allocated using table of random numbers by pharmacy to one of three groups (antibiotic irrigation, placebo irrigation, no irrigation); vitamin solution added to make placebo visually identical; physicians and patients blinded to treatment.

Participants

All women undergoing cesarean section (19/60 women had ruptured membranes >6 hours; 40/60 were in active labour).
Exclusion: known infection, currently on antibiotics, allergic to penicillin or cephalosporin.
Setting: Tripler Army Medical Center, Honolulu, Hawaii, US.

Interventions

Cefamandole 2g in 800ml normal saline irrigation (n = 30) versus irrigation with 800 ml normal saline (n = 30). Non‐irrigation control group (n = 30) not included.

Outcomes

Endomyometritis (fever, unusual uterine and parametrial tenderness without evidence of other source of infection); maternal length of stay.

Notes

Length of hospital stay for the control group included results from both the no irrigation group and the placebo irrigation group (5.37 days vs 4.53 for treatment group).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Randomized, placebo‐controlled.

Participants

Women in active labor undergoing cesarean section.
Exclusion: Elective cesarean section, evidence of infection, antibiotic use within 8 days, metronidazole intolerance, lack of consent.
Setting:Hospital Central Militar, Mexico city, Mexico.
Women predominantly (78%) of low socioeconomic level.

Interventions

Metronidazole 1g IV (n = 50) versus identical appearing placebo (n = 50) immediately after cord clamping.

Outcomes

Endometritis (purulent and/or foul odor lochia); wound infection (wound edges tender, red and swollen, or frank pus or sanguino‐purulent material exuded); urinary tract infection (bacteria seen in sediment) ; maternal hospital stay.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized, double‐blind, placebo controlled.
One woman initially randomized not included in analysis.

Participants

High risk women undergoing cesarean section (in active labour and/or ruptured membranes >4hours); classified as non‐elective in this review.
Exclusion: active infection, fever, antibiotic use within 3 days, allergy to penicillin or cephalosporins.
Setting: Fairfax Hospital, Virginia, US.
Women predominantly private.

Interventions

Ceftizoxime 2g (n = 50) versus placebo (n = 49) IV at time of cord clamping.

Outcomes

Febrile morbidity (oral temperature >37.9 degrees C twice at least 8 hr apart, after first 24 hr); endometritis (fever and foul lochia or uterine tenderness); urinary tract infection (fever and positive culture); wound infection (fever, abnormal‐looking wound, surrounded by cellulitis and/or draining purulent material).

Notes

Ceftizoxime is a third generation cephalosporin with broad aerobic and anaerobic activity.
There was one drug reaction (maculopapular rash) in the treatment group.
Women followed up at 6 weeks.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Double‐blind, randomized, placebo‐controlled.

Participants

Women undergoing cesarean deliveries for various indications.
Setting: Jacksonville, Florida, USA.

Interventions

Metronidazole gel 5g intravaginally (n = 31) vs matching placebo (n = 32).

Outcomes

Endometritis.

Notes

Abstract only.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomly assigned; not placebo controlled.
One woman was excluded because of an allergic reaction to cefuroxime (included in intent to treat analysis).

Participants

Women undergoing emergency cesarean section (58/60 women in spontaneous labor; classified as non‐elective).
Exclusion: allergy to penicillin or cephalosporins; severe renal disease, history of pelvic infections.
Setting: University of Parma, Parma, Italy, November 1981‐March 1982.

Interventions

Cefuroxime 750mg IM 30‐60 minutes before surgery and 8 and 16 hours after (short term)(n = 20) versus 750mg three times a day for five days (first dose being given post‐operatively after the woman had returned to the ward) (long term) (n = 20) versus no treatment (n = 20). The results of both treatment groups have been combined.

Outcomes

Fever (>100.3 degrees fahrenheit twice 6 hr apart); endometritis (fever and uterine tenderness); maternal stay (treatment 7.1 vs control 7.9 days, no variance given).

Notes

Note: the group given long‐term prophylaxis received the first dose after return to the ward.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Randomly referred'; not placebo controlled.

Participants

Women with rupture of membranes for >6 hours (equivalent to non‐elective group).
Exclusion: fever or foul smell of amniotic fluid.
Setting: Sodersjukhuset, Stockholm, Sweden, November 1983‐October 1984.

Interventions

Cefuroxime 1.5g IV q8hr for 24 hours, starting immediately before or during the operation, followed by oral cefadroxil 500mg twice daily for 6 days (n = 26) versus no treatment (n = 27).

Outcomes

Endometritis (marked uterine tenderness with or without a foul discharge with fever at least twice); wound infection (redness, tenderness, induration and pus in the wound); urinary tract infection (positive culture).

Notes

Data provided (but not included) for a second control group eligible for inclusion but not randomized.
Numbers not provided to calculate mean maternal length of stay for the two randomized groups.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized using consecutively numbered. sealed envelopes to treatment groups or no treatment. 14 patients excluded from study (8/147 from treatment groups, 6/51 from control group); included in intent to treat analysis.

Participants

Women undergoing elective caesarean section. Exclusion: hypersensitivity to penicillin or cephalosporin; prior antibiotic therapy within 3 days; hepatorenal insufficiency; positive cultures or definite evidence of infection.
Setting: United Arab Emirates.

Interventions

Pipericillin 4g intravenously after the cord was clamped (n = 48) vs cephadrine 500mg plus metronidazole 500mg both intravenously after the cord was clamped and every 8 hours x 2 (n = 47) vs pipericillin 2g intravenously after clamping of the cord and 2g every 8 hours x 2 (n = 52) vs no treatment (n = 51).

Outcomes

Febrile morbidity (fever >38 degrees C twice 4 hours apart after first day); endometritis (uterine and parametrial tenderness, foul smelling vaginal discharge); wound infection (local induration and tenderness with wound exudate).

Notes

Three patients who developed drug reactions were excluded from study (one from each of the treatment groups). Late morbidity evaluated at 4‐6 weeks.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomly allocated (individually randomized block ensuring two‐to‐one randomization at each centre); placebo‐controlled; women and investigators blind to allocation throughout the study.
Part of a larger study looking at prophylaxis also in gynecologic surgery; drop‐outs in cesarean section women not stated (overall: 11/319 from treated group, 8/172 from placebo group.

Participants

All women undergoing cesarean section (46% in labor).
Exclusion: infection, allergy to penicillin or cephalosporins.
Setting: 14 US centers, July 1976‐June 1978.

Interventions

Cephradine 1g IV (n = 133) versus placebo (n = 66) within 1 hour prior to surgery, repeated at 4 hours.

Outcomes

Febrile morbidity (oral temperature >37.7 degrees C twice 4 hours apart, after first 48 hours); endometritis (uterine tenderness, fever and purulent discharge), wound infection (increased local tenderness, redness or swelling); urinary tract infection (positive culture); maternal length of stay (treatment 5.8 days vs placebo 7.57 days; p<0.05, variance not given).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomly assigned, placebo‐controlled.
7 women (one in treatment, six in placebo group) initially randomized but results not included, 6 because they failed to receive all 3 doses, one because of hypotensive episode with first dose; intent to treat analysis performed.

Participants

All women in labour or with ruptured membranes (duration of ruptured membranes not stated; mean duration 9.97 hours; included in non‐elective category).
Setting: 5 centres in Canada.

Interventions

Cefoxitin 2g (n = 124) versus cefazolin 1g (n = 120) versus placebo (n = 117) infused intravenously immediately after cord clamped and 6 and 12 hours later. Results of both treatment groups combined.

Outcomes

Febrile morbidity (oral temperature >37.9 degrees C twice at least 6 hours apart after first 24 hours); wound infection (redness, induration, tenderness and/or purulent discharge from the incision line); endometritis/parametritis (uterine and/or adnexal tenderness with fever) urinary tract infection (dysuria or pyuria and positive culture); need for antibiotic therapy (11% for treatment groups vs 27% for placebo); maternal length of stay (7.3 and 7.4 days for treatment groups vs 7.9 for placebo).

Notes

Side‐effects documented: two infusion‐related hypotensive episodes (one with cefazolin, one with placebo that necessitated withdrawal from study); six episodes of phlebitis (five in treated, one in placebo group); one episode of angioedema (placebo patient). Data provided on antibiotic resistance in wound isolates and screening cervical cultures. One episode of bacteremia (in placebo group); one episode of septic shock (in cefazolin‐treated group); both outcomes included as serious morbidity.
Follow‐up at 6 weeks.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized as determined by table of random numbers; placebo‐controlled; double‐blind
14 women (7 in each group) initially randomized were later excluded but have been included in intent to treat analysis.

Participants

Women undergoing primary cesarean section (inclusion criteria not consistent with the definition of non‐elective cesarean section used in this review).
Exclusion: <18 years of age, membranes ruptured >35 hours, allergy to penicillin or cephalosporin, fever, infection or antibiotic use, significant underlying cardiac, renal or hepatic disease, unable to provide consent.
Setting: Beth Israel Hospital, Boston, Massachusetts, US, September 1978‐June 1980.

Interventions

Cefoxitin 2g IV immediately after the cord was clamped and at 4 and 8 hours (n = 52) versus matched placebo (mannitol with riboflavin) (n = 61).

Outcomes

Febrile morbidity (oral temperature >37.9 degrees C twice at least 6 hours apart after first 24 hours); urinary tract infection (positive culture); wound infection (purulence, cellulitis or dehiscence); endometritis (fever, uterine tenderness, abnormal lochia); septicemia (positive blood culture in a clinically septic patient); additional antibiotic use (8 in treatment group vs 12 in placebo).

Notes

Both episodes of septicemia occurred in the placebo group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Alternate patients undergoing caesarean section allocated to treatment or no treatment.

Participants

Women undergoing cesarean section (both elective and emergency).
Exclusion: on antibiotics, adverse reaction to penicillin or cephalosporin, pyrexia > 37.5 degrees C in labour, known vaginal pathogen, or suspected intrauterine infection.
Setting: Hammersmith Hospital (n = 102) and Northwick Park Hospital (n = 99), London, England.

Interventions

Cephradine 2g intravenously after induction of anesthesia and 1g 6 and 12 hours after the operation (n = 101) vs no treatment (n = 100).

Outcomes

Puerperal infection (temperature >37.5 degrees C after 24 hours); endometritis (pyrexia with uterine or adnexal tenderness); wound infection (purulent discharge or erythema, induration and serous discharge with positive culture); urinary tract infection (>100,000 colony forming units in urine culture); length of hospital stay (7.63 for treatment group, 7.18 for control group [SD not provided]).

Notes

Definitions of elective and emergency procedure, nor separate outcomes for each group, provided.
Follow‐up completed 1987.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate

Methods

Selected in a random manner; double‐blind; placebo‐controlled.

Participants

Women in labour (non‐elective).
Exclusion: acute bleeding due to abruptio placentae, established infection.
Setting: Alexandra Maternity Hospital, Athens, Greece.

Interventions

Cefuroxime 750mg IV within 1 hour of surgery and every 8 hours for 72 hours (n = 46) versus matching placebo (comparable in appearance and viscosity) (n = 50).

Outcomes

Febrile morbidity (oral temperature of >100.3 degrees fahrenheit twice 6 hours apart) and infection of endometrium, urinary tract and wound (not defined); results of duration of maternal stay only provided for febrile patients.

Notes

No patients had any major complications from the use of cefuroxime.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Allocated 'in random form' using a random table; not placebo‐controlled.

Participants

Women undergoing urgent cesarean section.
Exclusion: fever, chorioamnionitis, penicillin allergy, antibiotic treatment in prior 2 weeks.
Setting: Coah, Mexico.

Interventions

Ampicillin 2g intravenously every 4 hours x 3 after clamping of cord (n = 59) vs no treatment.

Outcomes

Febrile syndrome; wound infection; abdominal wall abscess; endometritis.

Notes

No definitions of outcomes provided.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

'Selected at random'; not placebo‐controlled.

Participants

Women undergoing primary cesarean section after the onset of labor.
Setting: Miami, Florida, US.
Mostly low‐income or indigent Negro women from ghetto areas of large metropolitan area.

Interventions

Penicillin G 2 million units IV every 4 hours and kanamycin 500mg IM every 12 hours as soon as it was decided to perform a cesarean section, at the time of operation or immediately post‐operatively and continued for a minimum of 3 days post‐operatively (n = 40) versus no treatment (n = 40).

Outcomes

Febrile morbidity (temperature of >100.3 degrees fahrenheit on any two days after first 24 hours); urinary tract infection, endometritis and wound infection (not defined); maternal length of stay (treatment 5.8 days vs 8.7 days for control group, no variance given).

Notes

One patient receiving penicillin had a drug rash on the third day.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized in numbered packages by the pharmacy department; placebo‐controlled; blinded.
Seven women initially randomized not included in final analysis (allocated group unknown).

Participants

Women with ruptured membranes who underwent internal fetal monitoring (not consistent with the definition of non‐elective used in this review).
Exclusion: fever, other antibiotic use, penicillin allergy.
Setting: Los Angeles County‐University of Southern California Medical Center, Los Angeles, California, US, January 1975‐January 1977; 87% Hispanic or Black.

Interventions

Cefazolin 1g IV after the cord was clamped and at 4‐6 hours and 10‐12 hours post‐operatively (n = 48) versus placebo (n = 45).

Outcomes

Standard temperature morbidity, endomyometritis, abdominal wound infection, urinary infections (no definitions provided for any outcomes).

Notes

Two women were said to develop a serious infection: one (cefazolin group) developed septic thrombophlebitis and is included as a serious outcome; the other (placebo group) was treated with antibiotics for prolonged fever (judged not to be a serious outcome for this review).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Selected in random, double‐blind manner; placebo‐controlled.

Participants

Women in labor.
Exclusion: acute bleeding due to abruptio placentae, infection on treatment; abnormal renal function, penicillin allergy.
Setting: University of Michigan Medical Center, Ann Arbour, Michigan, US.

Interventions

Cephalothin 2g IV within one hour of operation and at 4 and 8 hours after (n = 40) versus comparable appearing placebo (n = 40).

Outcomes

Febrile morbidity (oral temperature >100.3 degrees fahrenheit twice 6 hours apart); infection of endometrium, urinary tract and wound (definitions not provided); fever index (40 degree hours for treatment group vs 83 for placebo group).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomized into three groups (irrigation vs systemic treatment vs no treatment).

Participants

Women undergoing both elective (n = 112) and non‐elective (n = 105) cesarean section. Only women undergoing an elective cesarean section were randomized to treatment or no treatment and have been included in analysis.
Setting: Beijing, China.

Interventions

Local irrigation with ampicillin 6g after delivery of the placenta (n = 39) vs penicillin 5.6 MU and gentamicin 240,000 U intravenously immediately after surgery and penicillin 1.6 MU and gentamicin 160,000 U per day intramuscularly x 3 days (n = 41) vs no treatment (n = 32).

Outcomes

Endometritis (presence of any 2 of following: temperature above 37.5 degrees C, uterine tenderness, foul vaginal discharge); abdominal wound infection (cellulitis with small amount of exudate within 2 months of operation); uterine incision infection (associated with late post‐partum haemorrhage); fever index.

Notes

Women undergoing non‐elective sections randomized to either treatment group (not included in this review).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Assigned by the anesthetist in a randomized, double‐blind manner; placebo‐controlled.

Participants

Women undergoing cesarean section.
Exclusion: penicillin allergy, current antibiotic use, fever, receipt of steroid injection.
Setting: Prince of Wales Hospital, Hong Kong.

Interventions

Augmentin 1.2g (amoxycillin sodium 1000mg and clavulanate potassium 200mg) in 10ml saline (n = 160) versus saline placebo (n = 160).

Outcomes

Febrile morbidity (2 oral temperatures >37.9 degrees C at least 6 hours apart after first 24 hours); bacteriuria at day 3 (classified in this review as urinary tract infection); wound infection (purulent discharge, cellulitis, tenderness and wound abscess requiring incision and drainage); endometritis (fever, pelvic pain, uterine tenderness, purulent vaginal discharge without signs of infection in the lower genital tract); duration of hospital stay.

Notes

Sub‐rectus Redivac drain routinely inserted.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Randomly assigned; placebo‐controlled; physician team blinded.

Participants

Women in labour with an intrauterine pressure catheter and fetal scalp electrode (non‐elective).
Exclusion: fever, significant systemic disease.
Setting: Los Angeles County‐University of Southern California Medical Center, Los Angeles, California, US.
Predominantly (91%) Hispanic or Black.

Interventions

Cefoxitin 1g IV at time of cord clamping and at 4 and 8 hours (n = 50) versus matching placebo (n = 50).

Outcomes

Endomyometritis, abdominal wound infection, serious complications; duration of maternal hospital stay (treatment 5.1 days vs control 5.9 days, not statistically significant, no variance given).

Notes

One case of septic pelvic thrombophlebitis occurred in the treatment group; there were 8 episodes of bacteremia in the control group vs one in the treatment group; both outcomes combined under serious morbidity.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear