McCormack 1987.
Methods | Design: randomised, placebo‐controlled, 3‐armed trial | |
Participants |
Number assigned: 825 women (macrolide arm 1, n = 174; macrolide arm 2, n = 224; placebo, n = 427) Age in years: N/A Setting: secondary care |
|
Interventions |
Indication: pregnant women harbouring genital Ureaplasma urealyticum or Mycoplasma hominis, or both Type of macrolide: arm 1: erythromycin estolate, arm 2: erythromycin stearate Route: per oral Dose per day: 1000 mg (both arms) Duration of treatment: 6 weeks (both arms) Total treatment dose: 42,000 mg (both arms) |
|
Outcomes |
Adverse events stated as an outcome in trial registration/protocol/paper: unclear Adverse events ascertainment: participant asked + clinical examination/lab tests Adverse events: data reported Antimicrobial resistance: not reported Death: not reported |
|
Funding sources | Study supported by the National Institute of Child Health and Human Development. | |
Notes |
Concomitant medication: unclear Note: type of erythromycin used is changed roughly halfway through the study period (stearate to estolate) due to the reporting of many adverse events. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation not described. |
Allocation concealment (selection bias) | Unclear risk | Allocation not described. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical‐appearing placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Pregnant women and clinicians blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Large dropout in all 3 groups ‐ only about 40% of women completed the study. However, adverse events presented for 91% of participants. |
Selective reporting (reporting bias) | Low risk | Adverse events not clearly stated as an outcome. Standardised ascertainment and adverse events reported. |
Other bias | Low risk | None were identified. |