Mitra 1997.

Methods	Randomized trial Study period: July 1994 through July 1996
Participants	Inclusion criteria: women with 1 of the following; (1) 2 temperatures of at least 100.4 °F (38 °C) more than 12 hours postpartum, (2) a single temperature of at least 102 °F (38.9 °C) in the first 12 postpartum hours, (3) diagnosis of chorioamnionitis in labor thought to require prophylactic antibiotic therapy, (4) diagnosis of postpartum endometritis after initial discharge from the hospital. Women with criteria 1 or 4 were considered to have endometritis Setting: Charlotte, North Carolina, USA Number of participants: n = 299 (endometritis participants only n = 141)
Interventions	Clindamycin 800 mg iv plus gentamicin 1.33 mg/kg body weight iv every 8 hours (n = 71) vs clindamycin 1200 mg iv every 12 hours and gentamicin 4 mg/kg body weight every iv 24 hours (n = 70)
Outcomes	Cure (average temperature not more than 99 °F (37.2 °C) and resolution of symptoms) Failure (elevated temperature after 72 hours of treatment, clinical deterioration, or the need for additional antibiotic or heparin treatment) Relapse (cure with subsequent wound infection, abscess or endometritis up to 6 weeks postpartum) Time to resolution of infection (time from first dose to last dose of antibiotic administered). This was 2.8 +/‐ 2.4 days versus 2.3 +/‐ 2.0 days for the conventional thrice‐daily vs once‐daily gentamicin groups respectively, P value 0.02 Patient charges for antibiotic treatment (medication and administration): total charges for antibiotic treatment was USD 442.49 per patient in the conventional thrice‐daily dosing group and USD 250.79 for the once‐daily gentamicin group Nephrotoxicity (0.5 mg/dL increase in serum creatinine over the baseline). 1 participant (once‐daily group) had a serum creatinine level of 2.3 after therapy that resolved spontaneously
Notes	27 women were excluded after enrolment for protocol violations; insufficient information on drop‐outs to include study in intention‐to‐treat analysis There were 102 cesarean birth and 39 vaginal birth participants in the endometritis categories The conventional thrice‐daily dosing treatment group had more cesarean births (56/71) than the once‐daily gentamicin treatment group (46/70), which could confound results such as length of treatment, which favored the once‐daily group Multiple logistic regression demonstrated that the experimental dosing was not more efficacious when mode of delivery was accounted for Pharmaceutical sponsorship ‐ none apparent
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated schedule
Allocation concealment (selection bias)	Low risk	Sequentially numbered sealed opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	States “Physicians were not blinded with respect to the dosing regimen.” Blinding not done, allocation evident
Blinding of outcome assessment (detection bias) All outcomes	High risk	Blinding not done for physicians, allocation evident
Incomplete outcome data (attrition bias) All outcomes	Low risk	27 (10%) excluded for protocol violations with reasons. All the women who randomized were included in the analysis
Selective reporting (reporting bias)	Unclear risk	The protocol is not available, insufficient information to permit judgement
Other bias	Low risk	Study appeared to be free of other sources of bias