Skip to main content
. 2014 Nov 6;2014(11):CD007772. doi: 10.1002/14651858.CD007772.pub3

Adair 1996.

Methods Randomised trial with allocation concealment using computer‐generated randomisation list. All participants, caregivers and outcome assessors were blinded to the treatment regimen.
Participants Intervention group: 60 pregnant women (mean age 24.5, SD 6.3) with gestational age more than 24 weeks (mean 39.8, SD 1.0).
Control group: 60 pregnant women (mean age 25.9, SD 6.3), (mean gestational age 39.9, SD 1.2).
Inclusion criteria: gestational age more than 24 weeks with MSAF complicating the intrapartum.
Exclusion criteria: women with penicillin and/or cephalosporin allergy, evidence of active infection, presence of intrauterine death, GA < 24 weeks, or history of antibiotics use in 7 days.
Location: North Carolina, United States.
Interventions Intervention: ampicillin‐sulbactam 3.0 g intravenous prepared in 100 mL fluid bags, and was repeated every 6 hours until delivery.
Control: normal saline infused as an IV bolus.
Outcomes Mother 
 Chorioamnionitis.
 Postpartum endometritis.
Neonatal 
 Number of NICU admissions.
 Incidence of sepsis (not defined), and adverse outcomes including enterocolitis and respiratory distress.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was performed using a computer‐generated list.
Allocation concealment (selection bias) Low risk Adequate: there was randomisation by computer‐generated list and both IV preparations were prepared by 1 of 2 research nurses who were not involved in this study.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Adequate: ampicillin‐sulbactam and normal saline were identically prepared. Both preparations were prepared by research nurses who were not involved in the clinical care of the women.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Adequate: all caregivers were blinded to the randomisation status of the woman.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Adequate: there were no withdrawals.
Selective reporting (reporting bias) Unclear risk Unclear, because we do not have access to this trial's protocol.
Other bias Low risk Study appeared to be free of other sources of bias.