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. |
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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. |
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Outcomes |
Mother
Chorioamnionitis.
Postpartum endometritis. Neonatal Number of NICU admissions. Incidence of sepsis (not defined), and adverse outcomes including enterocolitis and respiratory distress. |
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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. |