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. 2019 Jan 18;2019(1):CD011825. doi: 10.1002/14651858.CD011825.pub2

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.